| Sphincterotome (K260962) | Taewoong Medical Co., Ltd. | 2026-05-21 |
| Vanquish Water Vapor Ablation Device (K252388) | Francis Medical, Inc. | 2025-11-26 |
| Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (K252889) | Olympus Medical Systems Corporation | 2025-11-25 |
| Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) (K250945) | Olympus Medical Systems Corp. | 2025-10-17 |
| Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) (K250351) | Olympus Medical Systems Corporation | 2025-10-10 |
| SureTome™ SW Sphincterotome with DomeTip (K251104) | Wilson-Cook Medical | 2025-09-29 |
| Aqua Medical RF Vapor Ablation System (K251226) | Aqua Medical, Inc. | 2025-08-08 |
| Rezum System (K250584) | Boston Scientific Corporation | 2025-06-11 |
| SpydrBlade Flex Instrument (PRD-RG1-001) (K242774) | Creo Medical, Ltd. | 2025-06-06 |
| SB Knife Jr2 (MD-47702 and MD-47702L) (K241855) | Sb-Kawasumi Laboratories, Inc. | 2025-03-26 |
| Disposable Sphincterotome (K242192) | Beijing Zksk Technology Co., Ltd. | 2025-02-06 |
| Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (K243568) | Wilson-Cook Medical, Inc. | 2025-01-17 |
| Aqua Medical RF Vapor Ablation System (K241271) | Aqua Medical, Inc. | 2024-12-12 |
| Reusable Interface Cable 1.5 m (PRD-IFC-002) (K242061) | Creo Medical, Ltd. | 2024-08-15 |
| Disposable Sphincterotome (K232825) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024-03-29 |
| Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter (K232633) | Boston Scientific | 2023-11-28 |
| Disposable Sphincterotome (K232476) | Zhejiang Soudon Medical Technology Co., Ltd. | 2023-11-07 |
| Speedboat Flush SB1 Instrument (K230328) | Creo Medical, Ltd. | 2023-10-31 |
| AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) (K233318) | Boston Scientific Corporation | 2023-10-27 |
| ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) (K233113) | Starmed Co., Ltd. | 2023-10-25 |
| Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome (K232162) | Boston Scientific Corporation | 2023-08-14 |
| Habib EndoHPB (K231533) | Boston Scientific Corporation | 2023-06-21 |
| Sphincterotome (K222421) | Hangzhou AGS MedTech Co., Ltd. | 2023-05-03 |
| Optimos™ Cystotome (K223256) | Taewoong Medical Co., Ltd. | 2023-04-05 |
| MCB UNIT Model: V10GMCBUS (K222542) | Lamidey Noury Medical | 2022-09-21 |
| Cysto-Gastro-Sets (K211909) | G-Flex Europe Sprl | 2022-06-09 |
| Multi-Functional Electrosurgical Knife (K212999) | Anrei Medical (Hangzhou) Co., Ltd. | 2022-03-21 |
| RF Vapor System (K213627) | Aqua Medical, Inc. | 2021-12-17 |
| Sphincterotome / short-wire compatible, Sterile Sphincterotome (K210934) | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-01 |
| Aqua Medical RF Vapor System (K211282) | Aqua Medical, Inc. | 2021-05-27 |
| Sphincterotome (K201121) | Hangzhou AGS MedTech Co., Ltd. | 2021-02-05 |
| ORISE ProKnife (K200404) | Boston Scientific Corporation | 2020-12-03 |
| Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) (K192342) | Hangzhou AGS MedTech Co., Ltd. | 2020-05-21 |
| Creo Electrosurgical System with HS1 Hemostasis Accessory (K192905) | Creo Medical, Ltd. | 2020-03-19 |
| TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord (K192339) | Wilson-Cook Medical, Inc. | 2020-01-30 |
| Single Use Balloon Dilator V (with knife) (K193039) | Olympus Medical Systems Corp. | 2019-12-17 |
| Rezum System (K191505) | Nxthera (A Boston Scientific Company) | 2019-08-02 |
| Aqua Medical RF Vapor System (K183595) | Aqua Medical, Inc. | 2019-06-21 |
| Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 (K182408) | Olympus Medical Systems Corp. | 2019-05-15 |
| SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long (K190621) | Sumitomo Bakelite Co., Ltd. | 2019-04-23 |
| ELRA Electrode (K181758) | Starmed Co., Ltd. | 2019-04-11 |
| Rezum Delivery Device, Rezum Generator (K190093) | Nxthera (A Boston Scientific Company) | 2019-03-25 |
| Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords (K172665) | Wilson-Cook Medical Inc./Cook Endoscopy | 2018-05-24 |
| Fusion OMNI Sphincterotome (K172288) | Wilson-Cook Medical Inc./Cook Endoscopy | 2018-04-17 |
| Habib EndoHPB (K180165) | Emcision , Ltd. | 2018-03-20 |
| Rezum System (K180237) | Nxthera, Inc. | 2018-02-27 |
| Barrx SB RFA Endoscopic Catheter (K173559) | Covidien, LLC | 2018-01-18 |
| Single Use Electrosurgical knife (K171158) | Olympus Medical Systems Corp. | 2017-11-17 |
| Zimmon Needle Knife Papillotome (K171993) | Wilson-Cook Medical Inc./Cook Endoscopy | 2017-08-17 |
| Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory (K171983) | Creo Medical, Ltd. | 2017-08-17 |
| SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long (K152771) | Sumitomo Bakelite Co., Ltd. | 2016-06-17 |
| Rezum System (K160417) | Nxthera, Inc. | 2016-03-17 |
| Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 (K160241) | Olympus Medical Systems Corp. | 2016-03-02 |
| Single Use Balloon Dilator V (with Knife) (K150142) | Olympus Medical Systems Corp. | 2015-10-08 |
| Rezum System (K150786) | Nxthera, Inc. | 2015-08-27 |
| SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP (K141991) | Olympus Medical Systems Copr. | 2015-03-31 |
| INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER (K133933) | Boston Scientific Corporation | 2014-04-02 |
| BARRX CHANNEL RFA ENDOSCOPIC CATHETER (K130623) | Covidien, LLC | 2013-07-26 |
| SINGLE USE PRELOADED SPHINCTEROTOME V (K122505) | Olympus Medical Systems Corp. | 2013-04-11 |
| GYRUS ACMI BICOAG HEMOSTASIS PROBE (K123319) | Olympus Surgical Technologies America | 2012-12-14 |
| TRUETOME (K122203) | Boston Scientific Corp | 2012-08-17 |
| INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER (K110887) | Boston Scientific Corporation | 2011-04-14 |
| GYRUS ACMI BIOCOAG PROBE (K092571) | Gyrus Acmi, Inc. | 2010-10-20 |
| MERIT BIPOLAR COAGULATION PROBE (K102273) | Merit Medical Systems, Inc. | 2010-09-07 |
| TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U (K093079) | Hobbs Medical, Inc. | 2010-08-02 |
| PROSTIVA RF THERAPY MODEL 8929 HAND PIECE (K101139) | Medtronic, Inc. | 2010-05-21 |
| SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L (K092309) | Olympus Medical Systems Corporation | 2009-10-30 |
| HABIB ENDOHPB (K083292) | Emcision , Ltd. | 2009-06-10 |
| PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 (K083275) | Max Endoscopy, Inc. | 2009-06-09 |
| ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 (K082114) | Apollo Endosurgery, Inc. | 2008-12-19 |
| PROSTIVA RF THERAPY HAND PIECE, MODEL 8929 (K082464) | Medtronic, Inc. | 2008-10-27 |
| CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX (K080946) | Conmed Endoscopic Technologies, Inc. | 2008-05-20 |
| HABIB ENDOBLATE (K072383) | Emcision , Ltd. | 2007-11-29 |
| MEDI-GLOBE ROTA-CUT SPHINCTEROTOME (K061684) | Medi-Globe Corporation | 2006-06-27 |
| TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 (K052413) | Medtronic Vascular | 2005-11-17 |
| OMNI SPHINCTEROTOME (K052051) | Wilson-Cook Medical, Inc. | 2005-08-05 |
| COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE (K050578) | Cook Ireland, Ltd. | 2005-04-22 |
| STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM (K033135) | Stryker Endoscopy | 2004-08-09 |
| USW NEEDLEKNIFE PAPILLOTOME (K040981) | Wilson-Cook Medical, Inc. | 2004-05-07 |
| WILSON-COOK TRI-TOME SELECT PLUS (K033203) | Wilson-Cook Medical, Inc. | 2003-12-19 |
| ETI BIPOLAR HEMOSTATIC PROBE (K031026) | Endo-Therapeutics, Inc. | 2003-06-27 |
| XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT (K030194) | The Olympus Optical Co. | 2003-03-24 |
| MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM (K030315) | Ultroid, LLC | 2003-02-27 |
| ULTROID HEMORRHOID MANAGEMENT SYSTEM (K023706) | Ultroid, LLC | 2003-01-14 |
| WILSON-COOK CYSTOTOME (K022595) | Wilson-Cook Medical, Inc. | 2002-10-17 |
| ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018 (K021266) | Ethicon Endo-Surgery, Inc. | 2002-09-27 |
| RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE (K012587) | Vidamed, Inc. | 2001-12-11 |
| AUTOTOME RX MODEL # 4515, 4516 (K013153) | Boston Scientific Corp | 2001-10-19 |
| PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE (K011787) | Vidamed, Inc. | 2001-07-06 |
| ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM (K010568) | Arthrocare Corp. | 2001-03-27 |
| TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM (K002583) | Vidamed, Inc. | 2001-02-13 |
| HORIZONS PAPILLOTOME (K002236) | Horizons Intl. Corp. | 2001-01-23 |
| PLASMAKINETIC ENDOUROLOGY SYSTEM (K003569) | Gyrus Medical , Ltd. | 2000-12-19 |
| RAPID EXCHANGE TAPERTOME (K002802) | Boston Scientific Corp | 2000-10-05 |
| THERMOFLEX SYSTEM (K000508) | Argomed, Inc. | 2000-04-18 |
| GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE (K994166) | Gyrus Medical , Ltd. | 1999-12-27 |
| 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH (K992402) | Telemed Systems, Inc. | 1999-12-22 |
| THERMOFLEX SYSTEM (K991847) | Argomed, Inc. | 1999-08-26 |
| GYRUS ENDOUROLOGY SYSTEM (K990628) | Gyrus Medical , Ltd. | 1999-06-29 |
| COOPERSURGICAL INFRARED COAGULATOR (K990852) | CooperSurgical, Inc. | 1999-06-11 |