| OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, (K260649) | Olympus Winter & Ibe GmbH | 2026-05-21 |
| CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) (K253696) | Verathon Medical (Canada) Ulc | 2026-05-11 |
| Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°, (K253892) | Strauss Surgical USA | 2026-04-16 |
| PrimeSight UltraView System (K253905) | Cogentix Medical, Inc. | 2026-04-07 |
| Strauss Surgical cystoscope, hysteroscope and accessories Instruments (K260271) | American Medical Endoscopy, Inc. | 2026-03-27 |
| UV5000W Handle (K253226) | Uroviu Corporation | 2025-10-23 |
| Zenflow Spring Scope (K251140) | Zenflow, Inc. | 2025-09-23 |
| Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (K252598) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-09-15 |
| UV5000 Handle (K250797) | Uroviu Corporation | 2025-09-11 |
| KARL STORZ HOPKINS Telescopes for Urology (K243653) | Karl Storz SE & CO. KG | 2025-08-13 |
| Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (K252176) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-08-08 |
| Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo (K251652) | American Medical Endoscopy, Inc. | 2025-08-01 |
| Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) (K250269) | Ambu A/S | 2025-06-11 |
| Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) (K242535) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-12-18 |
| Uro-G HD Cystoscope (1520) (K243196) | Uroviu Corporation | 2024-12-13 |
| Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 (K240849) | Ambu A/S | 2024-10-16 |
| Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance (K240848) | Ambu A/S | 2024-10-10 |
| LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) (K240227) | Lina Medical Aps | 2024-08-22 |
| Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (K241500) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-07-12 |
| Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) (K240663) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-06-21 |
| BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) (K240283) | MacroLux Medical Technology Co., Ltd. | 2024-06-10 |
| Uro-G HD Flexible Cystoscope (K232837) | Uroviu Corporation | 2024-06-07 |
| Cystoscope System (K231118) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2023-11-13 |
| VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box (K223926) | Medimaging Integrated Solution, Inc (Miis) | 2023-10-06 |
| WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet (K231702) | OTU Medical, Inc. | 2023-09-29 |
| Endo SmartCap (K223040) | Medivators, Inc. | 2023-03-01 |
| CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) (K221683) | Olympus Medical Systems Corporation | 2023-01-20 |
| OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) (K221690) | Olympus Medical Systems Corp. | 2022-12-29 |
| Single-Use Flexible Cystoscope (K221580) | Hunan Vathin Medical Instrument Co., Ltd. | 2022-11-18 |
| Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (K222162) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-11-09 |
| Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300) (K222602) | Zhuhai Pusen Medical Technology Co., Ltd. | 2022-09-26 |
| WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System (K212202) | OTU Medical, Inc. | 2022-04-13 |
| KARL STORZ Flexible HD Cysto-Urethroscope System (K212476) | Karl Storz Endoscopy America, Inc. | 2021-09-03 |
| LUMINELLE DTx System (K210512) | Uvision360, Inc. | 2021-06-30 |
| Uro-G Cystoscope (K202921) | Uroviu Corporation | 2021-05-04 |
| Flexible Video Cysto-Urethroscope (C-view) (K202957) | KARL STORZ Endoscopy-America, Inc. | 2020-10-29 |
| Ambu aScope 4 Cysto (K193095) | Ambu A/S | 2020-04-02 |
| Flexible HD Cysto-Urethroscope System (K191357) | KARL STORZ Endoscopy-America, Inc. | 2019-09-18 |
| Uro-N Cystoscope (K182876) | Uroviu Corporation | 2019-07-02 |
| Flexible HD Cysto-Urethroscope System (K182723) | KARL STORZ Endoscopy-America, Inc. | 2019-04-23 |
| Luminelle DTx Hysteroscopy System (K181909) | Uvision360, Inc. | 2018-08-16 |
| Uro-V Cystoscope (K171500) | Uroviu Corporation | 2018-01-30 |
| Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope (K170862) | Solace Therapeutics, Inc. | 2017-12-19 |
| Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath (K171336) | Henke-Sass, Wolf GmbH | 2017-12-07 |
| Ambu USR, Ambu M (K160766) | Ambu A/S | 2016-08-17 |
| CytoSure Urinary Access System (K142194) | Emmy Medical | 2014-12-19 |
| ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) (K120766) | Prosurg, Inc. | 2012-09-11 |
| CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C (K093725) | Canada Endoscope Corporation | 2010-08-30 |
| ENDO SMARTCAP (K093665) | Byrne Medical, Inc. | 2009-12-15 |
| MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 (K090814) | Gyrus Acmi, Inc. | 2009-04-20 |
| VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM (K072180) | Vision-Sciences, Inc. | 2007-12-18 |
| FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE (K060899) | Schoelly Imaging, Inc. | 2007-03-02 |
| MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE (K053560) | Vision-Sciences, Inc. | 2006-03-16 |
| FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066 (K051176) | Richard Wolf Medical Instruments Corp. | 2005-10-05 |
| STRYKER FLEXIBLE CYSTONEPHROSCOPE (K043022) | Stryker Endoscopy | 2005-03-15 |
| NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (K042780) | Prosurg, Inc. | 2005-02-03 |
| ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 (K042225) | Acmi Corporation | 2004-09-10 |
| VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM (K040215) | Vision-Sciences, Inc. | 2004-04-15 |
| SOHNIKS (K033191) | Sohniks Endoscopy, Inc. | 2004-03-09 |
| ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE (K030960) | Acmi Corporation | 2003-07-16 |
| ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE (K031141) | Asap Endoscopic Products GmbH | 2003-06-30 |
| VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA (K021074) | Olympus America, Inc. | 2002-05-02 |
| FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 (K012929) | Circon Video | 2001-11-19 |
| UROSCOPE, ARTES MEDICAL, USA (K003988) | Artes Medical USA, Inc. | 2001-09-06 |
| CYSTOSCOPES (K003807) | Global Endoscopy, Inc. | 2001-02-22 |
| OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT (K993041) | The Olympus Optical Co. | 2000-03-30 |
| CORTEK CYSTOSCOPE (K000197) | Cortek Endoscopy, Inc. | 2000-03-03 |
| AED CYSTOSCOPE (K993689) | National Advanced Endoscopy Devices, Inc. | 1999-12-15 |
| BAHO AUTOCLAVABLE CYSTOSCOPE (K992983) | Innovative Endoscopy Components, LLC | 1999-10-07 |
| MEDIFIX INC. (K992483) | Medifix, Inc. | 1999-08-30 |
| MEDIVISION CYSTOSCOPE (K982620) | Medivision Scope Service Center, Inc. | 1998-09-30 |
| FLEXIBLE FIBERSCOPES AND ACCESSORIES (K980401) | Richard Wolf Medical Instruments Corp. | 1998-05-21 |
| NTECH CYSTOSCOPES (K980592) | N-Tech Endoscopy, Inc. | 1998-04-28 |
| FIEGERT ENDOTECH CYSTOSCOPE (K970892) | Fiegert, Inc. | 1997-05-05 |
| FLEXIBLE CYSTOSCOPE (K964037) | Applied Fiberoptics, Inc. | 1997-02-20 |
| CYSTOSCOPE 0/15/30/70 DEGREES (K960872) | Pollux Endoscopy, Inc. | 1996-05-07 |
| IMAGYN UROSCOPE (K953201) | Imagyn Medical, Inc. | 1995-08-02 |
| OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES (K945262) | Optus, Inc. | 1995-05-26 |
| KARL STORZ TELESCOPE BRIDGES AND ADAPTERS (K945527) | KARL STORZ Endoscopy-America, Inc. | 1994-12-23 |
| KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ (K943176) | KARL STORZ Endoscopy-America, Inc. | 1994-12-21 |
| KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE (K941779) | KARL STORZ Endoscopy-America, Inc. | 1994-06-27 |
| KARL STORZ FIXED MAGNIFICATION TELESCOPE/KARL STORZ VARIABLE MAGNIFICATION TELESCOPE (K935278) | KARL STORZ Endoscopy-America, Inc. | 1994-06-24 |
| BARD STABILIZING CANNULA (K930827) | C.R. Bard, Inc. | 1993-05-14 |
| OMNI CYSTOSCOPE (K922320) | Expanded Optics, Inc. | 1993-01-13 |
| PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P (K914008) | Pentax Precision Instrument Corp. | 1992-01-10 |
| CUSTOMED CYSTO PACK I (K902274) | Customed, Inc. | 1990-09-20 |
| ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY (K895182) | Advanced Surgical Intervention, Inc. | 1989-10-24 |
| LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35 (K860822) | Cooper Lasersonics, Inc. | 1986-04-17 |
| CURITY ECONOMY II CYSTOSCOPY TRAY (K820851) | The Kendal Co. | 1982-05-13 |
| SHEATH, CYSTOURETHROSCOPE W/ OBTURATOR (K760179) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 |
| STOPCOCK, WATERLINE (K760189) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-12-02 |
| TIP, RUBBER, PERFORATED (K760274) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-08-30 |