| Zamenix™ P (K253505) | Roen Surgical, Inc. | 2026-08-07 |
| BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) (K260516) | MacroLux Medical Technology Co., Ltd. | 2026-07-20 |
| Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) (K252929) | Anhui Happiness Workshop Instruments Co., Ltd. | 2026-04-09 |
| CVAC Image Processor (K260013) | Calyxo, Inc. | 2026-03-06 |
| Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) (K252468) | Zhejiang Geyi Medical Instrument Co., Ltd. | 2025-12-16 |
| Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) (K251951) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-12-16 |
| Miniature Telescope for Urology (27033AA) (K253411) | Karl Storz SE & CO. KG | 2025-11-18 |
| Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) (K250917) | Shenzhen Sanping Image Technology Co., Ltd. | 2025-10-31 |
| Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) (K252806) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-10-03 |
| LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) (K252703) | Boston Scientific Corporation | 2025-09-24 |
| Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) (K250049) | Seplou (Zhuhai) Co., Ltd. | 2025-08-26 |
| KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) (K243550) | Karl Storz SE & CO. KG | 2025-06-06 |
| Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) (K242699) | Opcom Medical, Inc. | 2025-05-28 |
| Single-use Flexible Ureteroscope (K250785) | Hunan Vathin Medical Instrument Co., Ltd. | 2025-05-06 |
| F88 URE-SD/RD Flexible Ureteroscope (K243894) | Sg Endoscopy Pte, Ltd. | 2025-05-02 |
| LumiRex Ureteroscope (K243532) | Contra Healthcare Solutions, LLC | 2025-04-28 |
| Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) (K243857) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-04-11 |
| Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) (K243708) | Scivita Medical Technology Co., Ltd. | 2025-03-27 |
| Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) (K243155) | Dongguan Zsr Biomedical Technology Company Limited | 2025-02-11 |
| Digital Video Processor (K243117) | Hunan Vathin Medical Instrument Co., Ltd. | 2025-01-29 |
| Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) (K241956) | Hunan Endoso Life Technology Co., Ltd. | 2025-01-22 |
| Video Ureteroscope System (K241434) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-04 |
| Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) (K240074) | Shenzhen Besdata Technology Co., Ltd. | 2024-10-04 |
| URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor) (K240203) | Dyne Medical Group, Inc. | 2024-09-05 |
| Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance (K242108) | Ambu A/S | 2024-08-16 |
| Avicenna Roboflex (K233700) | Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi | 2024-08-16 |
| KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1) (K241945) | Karl Storz SE & CO. KG | 2024-08-01 |
| KARL STORZ Fiber Telescopes for Urology (K233372) | Karl Storz SE & CO. KG | 2024-07-25 |
| Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) (K233778) | Zhuhai Pusen Medical Technology Co., Ltd. | 2024-07-16 |
| LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring) (M0067941500) (K241598) | Boston Scientific Corporation | 2024-07-01 |
| Single-use Video Ureterorenoscope (SVU-220US) (K241639) | Huger Medical Instrument Co., Ltd. | 2024-07-01 |
| Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2 (K233630) | Ambu A/S | 2024-06-24 |
| KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1) (K232911) | Karl Storz Endovision, Inc. | 2024-06-10 |
| Ureterorenoscope System (K240374) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-05-10 |
| RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) (K233275) | Gyrus Acmi, Inc. | 2024-03-25 |
| Video Ureteroscope System (K231135) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-01-17 |
| CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) (K231774) | MacroLux Medical Technology Co., Ltd. | 2024-01-11 |
| StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection (K233645) | Boston Scientific Corporation - | 2023-12-12 |
| Medical Video Endoscope System (K230475) | Huger Medical Instrument Co., Ltd. | 2023-11-03 |
| RenaNav Ureteroscope System (K223097) | CenterPoint Systems, LLC | 2023-07-31 |
| Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 (K231878) | STERIS Corporation | 2023-07-25 |
| Single-Use Flexible Ureteroscope (K230200) | Hunan Vathin Medical Instrument Co., Ltd. | 2023-05-18 |
| Single-Use Video Flexible Ureterorenoscope System (K221158) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2023-03-06 |
| Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 (K223466) | STERIS Corporation | 2023-02-17 |
| StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring (K221515) | Boston Scientific Corporation | 2023-02-02 |
| Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) (K222737) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-10-05 |
| Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) (K220159) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-08-26 |
| Monarch Platform, Urology (K213334) | Auris Health, Inc. | 2022-04-29 |
| Flexible Video-Choledo-Cysto-Ureteroscope System (K211686) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2022-02-22 |
| Flexible Video-Uretero-Renoscope SSU System (K212458) | Karl Storz Endoscopy America | 2022-01-20 |
| Uretero1 Ureteroscope System (K211347) | STERIS Corporation | 2021-11-23 |
| WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System (K210579) | OTU Medical, Inc. | 2021-07-22 |
| Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 (K201897) | Richard Wolf Medical Instruments Corporation | 2021-01-15 |
| OES Elite Ureteroscopes and Accessories (K200369) | Olympus Winter & Ibe GmbH | 2020-08-28 |
| Ureterorenoscope System (K201293) | Shanghai AnQing Medical Instrument Co., Ltd. | 2020-07-24 |
| Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF (K183188) | Richard Wolf Medical Instruments Corporation | 2019-05-03 |
| URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R (K181451) | Olympus Medical Systems Corp. | 2019-01-16 |
| WiScope Digital Endoscope System (K181977) | OTU Medical, Inc. | 2018-08-14 |
| Ureterorenoscope System (K180367) | Shanghai AnQing Medical Instrument Co., Ltd. | 2018-07-03 |
| OLYMPUS URF-V2/V2R (K172246) | Olympus Medical Systems Corp. | 2018-03-30 |
| OLYMPUS URF-P6/P6R (K172298) | Olympus Medical Systems Corp. | 2018-03-29 |
| Medical Video Endoscope System (K172098) | Zhuhai Pusen Medical Technology Co., Ltd. | 2017-08-31 |
| Medical Video Endoscope System (K171076) | Zhuhai Pusen Medical Technology Co., Ltd. | 2017-05-05 |
| LithoVue System (K153049) | Boston Scientific Corporation | 2015-11-13 |
| Flexible Video-Uretero-Choledochoscope System (K142556) | KARL STORZ Endoscopy-America, Inc. | 2014-10-23 |
| FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM (K141250) | KARL STORZ Endoscopy-America, Inc. | 2014-06-11 |
| FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM (K131369) | KARL STORZ Endoscopy-America, Inc. | 2013-11-26 |
| STRYKER VIDEO URETEROSCOPE (K121112) | Stryker Endoscopy | 2012-09-12 |
| MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM (K111480) | Technology Delivery Systems, Inc. | 2012-04-04 |
| RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE (K062707) | Innovative Endoscopy Components, LLC | 2006-12-08 |
| MAXIFLEX-SEMI FLEX SCOPE (K062725) | Technology Delivery Systems, Inc. | 2006-09-29 |
| ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL (K052044) | Acmi Corporation | 2005-08-16 |
| STRYKER URETEROSCOPE (K043021) | Stryker Endoscopy | 2005-03-16 |
| OLYMPUS VIDEO URETEROSCOPE, NTSC (K033651) | Olympus Winter & Ibe GmbH | 2004-01-30 |
| STRYKER FLEXIBLE URETEROSCOPE (K031278) | Stryker Endoscopy | 2003-10-16 |
| USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8 (K023358) | Acmi Corporation | 2003-01-03 |
| URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L, (K012758) | Circon Video | 2002-04-09 |
| MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS (K011849) | Circon Video | 2001-12-10 |
| APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE (K012951) | Circon Video | 2001-11-09 |
| DUR-8, MODELS DUR-8 (K012925) | Circon Video | 2001-11-07 |
| MEDIFIX URETEROSCOPE (K011325) | Medifix, Inc. | 2001-07-25 |
| URETEROSCOPES (K003806) | Global Endoscopy, Inc. | 2001-02-22 |
| CORTEK URETHEROSCOPE (K000200) | Cortek Endoscopy, Inc. | 2000-03-03 |
| URETERO-RENOSCOPE (K992527) | Fiber Imaging Technologies, Inc. | 1999-10-13 |
| FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253 (K991178) | Richard Wolf Medical Instruments Corp. | 1999-06-11 |
| URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042 (K990050) | Richard Wolf Medical Instruments Corp. | 1999-03-26 |
| MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE (K982905) | Karl Storz Endoscopy | 1998-10-05 |
| 12 URETEROSCOPES/URETERO-RENOSCOPES (K963855) | Richard Wolf Medical Instruments Corp. | 1997-04-03 |
| KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE (K970427) | Karl Storz Endoscopy | 1997-03-11 |
| FLEXIBLE URETEROSCOPE (K964482) | Applied Fiberoptics, Inc. | 1997-01-24 |
| KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE (K960323) | KARL STORZ Endoscopy-America, Inc. | 1996-04-22 |
| ULTRATHIN URETEROSCOPES (K951855) | Olympus America, Inc. | 1995-08-16 |
| HMT ALEXCOPE (K941013) | Servicetrends, Inc. | 1995-02-09 |
| KARL STORZ URETERO-RENOSCOPE/URETERSCOPE (K940464) | KARL STORZ Endoscopy-America, Inc. | 1994-06-24 |
| THE KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE (K925128) | KARL STORZ Endoscopy-America, Inc. | 1993-08-18 |
| S/2(TM) STOPCOCK (K926423) | Psi Medical Products, Inc. | 1993-03-23 |
| ENDOSCOPE AND ACCOSSORIES (K926004) | Endomedix | 1993-02-10 |
| BARD 7 FR. FIBER OPTIC ASSEMBLY (K923545) | C.R. Bard, Inc. | 1992-10-08 |
| BARD URETEROSCOPE DEFLECTION MODULE (K920750) | C.R. Bard, Inc. | 1992-04-16 |
| URETEROSCOPE (K915458) | Psi Medical Products, Inc. | 1992-01-30 |