FDA Product Code
FDA Product Code KNS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4300
510(k) Clearances — 189 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262460 | Rezum System | Boston Scientific | 2026-09-03 | Traditional | PDF ↗ |
| K260962 | Sphincterotome | Taewoong Medical Co., Ltd. | 2026-05-21 | Traditional | PDF ↗ |
| K252388 | Vanquish Water Vapor Ablation Device | Francis Medical, Inc. | 2025-11-26 | Traditional | PDF ↗ |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corporation | 2025-11-25 | Traditional | PDF ↗ |
| K250945 | 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) | Olympus Medical Systems Corp. | 2025-10-17 | Traditional | PDF ↗ |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) | Olympus Medical Systems Corporation | 2025-10-10 | Traditional | PDF ↗ |
| K251104 | SureTome SW Sphincterotome with DomeTip | Wilson-Cook Medical | 2025-09-29 | Traditional | PDF ↗ |
| K251226 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | 2025-08-08 | Traditional | PDF ↗ |
| K250584 | Rezum System | Boston Scientific Corporation | 2025-06-11 | Traditional | PDF ↗ |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) | Creo Medical, Ltd. | 2025-06-06 | Traditional | PDF ↗ |
| K241855 | SB Knife Jr2 (MD-47702 and MD-47702L) | Sb-Kawasumi Laboratories, Inc. | 2025-03-26 | Traditional | PDF ↗ |
| K242192 | Disposable Sphincterotome | Beijing Zksk Technology Co., Ltd. | 2025-02-06 | Traditional | PDF ↗ |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical, Inc. | 2025-01-17 | Special | PDF ↗ |
| K241271 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | 2024-12-12 | Traditional | PDF ↗ |
| K242061 | Reusable Interface Cable 1.5 m (PRD-IFC-002) | Creo Medical, Ltd. | 2024-08-15 | Special | PDF ↗ |
| K232825 | Disposable Sphincterotome | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024-03-29 | Traditional | PDF ↗ |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific | 2023-11-28 | Traditional | PDF ↗ |
| K232476 | Disposable Sphincterotome | Zhejiang Soudon Medical Technology Co., Ltd. | 2023-11-07 | Traditional | PDF ↗ |
| K230328 | Speedboat Flush SB1 Instrument | Creo Medical, Ltd. | 2023-10-31 | Traditional | PDF ↗ |
| K233318 | 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) | Boston Scientific Corporation | 2023-10-27 | Special | PDF ↗ |
| K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) | Starmed Co., Ltd. | 2023-10-25 | Special | PDF ↗ |
| K232162 | 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 | Boston Scientific Corporation | 2023-08-14 | Special | PDF ↗ |
| K231533 | Habib EndoHPB | Boston Scientific Corporation | 2023-06-21 | Special | PDF ↗ |
| K222421 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2023-05-03 | Traditional | PDF ↗ |
| K223256 | Optimos Cystotome | Taewoong Medical Co., Ltd. | 2023-04-05 | Traditional | PDF ↗ |
| K222542 | MCB UNIT Model: V10GMCBUS | Lamidey Noury Medical | 2022-09-21 | Traditional | PDF ↗ |
| K211909 | Cysto-Gastro-Sets | G-Flex Europe Sprl | 2022-06-09 | Traditional | PDF ↗ |
| K212999 | Multi-Functional Electrosurgical Knife | Anrei Medical (Hangzhou) Co., Ltd. | 2022-03-21 | Traditional | PDF ↗ |
| K213627 | RF Vapor System | Aqua Medical, Inc. | 2021-12-17 | Special | PDF ↗ |
| K210934 | Sphincterotome / short-wire compatible, Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-01 | Traditional | PDF ↗ |
| K211282 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2021-05-27 | Special | PDF ↗ |
| K201121 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2021-02-05 | Traditional | PDF ↗ |
| K200404 | ORISE ProKnife | Boston Scientific Corporation | 2020-12-03 | Traditional | PDF ↗ |
| K192342 | Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) | Hangzhou AGS MedTech Co., Ltd. | 2020-05-21 | Traditional | PDF ↗ |
| K192905 | Creo Electrosurgical System with HS1 Hemostasis Accessory | Creo Medical, Ltd. | 2020-03-19 | Traditional | PDF ↗ |
| K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | Wilson-Cook Medical, Inc. | 2020-01-30 | Traditional | PDF ↗ |
| K193039 | Single Use Balloon Dilator V (with knife) | Olympus Medical Systems Corp. | 2019-12-17 | Traditional | PDF ↗ |
| K191505 | Rezum System | Nxthera (A Boston Scientific Company) | 2019-08-02 | Special | PDF ↗ |
| K183595 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2019-06-21 | Traditional | PDF ↗ |
| K182408 | Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 | Olympus Medical Systems Corp. | 2019-05-15 | Traditional | PDF ↗ |
| K190621 | SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long | Sumitomo Bakelite Co., Ltd. | 2019-04-23 | Traditional | PDF ↗ |
| K181758 | ELRA Electrode | Starmed Co., Ltd. | 2019-04-11 | Traditional | PDF ↗ |
| K190093 | Rezum Delivery Device, Rezum Generator | Nxthera (A Boston Scientific Company) | 2019-03-25 | Special | PDF ↗ |
| K172665 | 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 | Wilson-Cook Medical Inc./Cook Endoscopy | 2018-05-24 | Traditional | PDF ↗ |
| K172288 | Fusion OMNI Sphincterotome | Wilson-Cook Medical Inc./Cook Endoscopy | 2018-04-17 | Traditional | PDF ↗ |
| K180165 | Habib EndoHPB | Emcision , Ltd. | 2018-03-20 | Traditional | PDF ↗ |
| K180237 | Rezum System | Nxthera, Inc. | 2018-02-27 | Special | PDF ↗ |
| K173559 | Barrx SB RFA Endoscopic Catheter | Covidien, LLC | 2018-01-18 | Special | PDF ↗ |
| K171158 | Single Use Electrosurgical knife | Olympus Medical Systems Corp. | 2017-11-17 | Traditional | PDF ↗ |
| K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory | Creo Medical, Ltd. | 2017-08-17 | Traditional | PDF ↗ |
| K171993 | Zimmon Needle Knife Papillotome | Wilson-Cook Medical Inc./Cook Endoscopy | 2017-08-17 | Traditional | PDF ↗ |
| K152771 | SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long | Sumitomo Bakelite Co., Ltd. | 2016-06-17 | Traditional | PDF ↗ |
| K160417 | Rezum System | Nxthera, Inc. | 2016-03-17 | Special | PDF ↗ |
| K160241 | Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 | Olympus Medical Systems Corp. | 2016-03-02 | Special | PDF ↗ |
| K150142 | Single Use Balloon Dilator V (with Knife) | Olympus Medical Systems Corp. | 2015-10-08 | Traditional | PDF ↗ |
| K150786 | Rezum System | Nxthera, Inc. | 2015-08-27 | Traditional | PDF ↗ |
| K141991 | SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP | Olympus Medical Systems Copr. | 2015-03-31 | Traditional | PDF ↗ |
| K133933 | INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER | Boston Scientific Corporation | 2014-04-02 | Special | PDF ↗ |
| K130623 | BARRX CHANNEL RFA ENDOSCOPIC CATHETER | Covidien, LLC | 2013-07-26 | Traditional | PDF ↗ |
| K122505 | SINGLE USE PRELOADED SPHINCTEROTOME V | Olympus Medical Systems Corp. | 2013-04-11 | Traditional | PDF ↗ |
| K123319 | GYRUS ACMI BICOAG HEMOSTASIS PROBE | Olympus Surgical Technologies America | 2012-12-14 | Special | PDF ↗ |
| K122203 | TRUETOME | Boston Scientific Corp | 2012-08-17 | Special | PDF ↗ |
| K110887 | INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER | Boston Scientific Corporation | 2011-04-14 | Special | PDF ↗ |
| K092571 | GYRUS ACMI BIOCOAG PROBE | Gyrus Acmi, Inc. | 2010-10-20 | Traditional | PDF ↗ |
| K102273 | MERIT BIPOLAR COAGULATION PROBE | Merit Medical Systems, Inc. | 2010-09-07 | Special | PDF ↗ |
| K093079 | TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U | Hobbs Medical, Inc. | 2010-08-02 | Traditional | PDF ↗ |
| K101139 | PROSTIVA RF THERAPY MODEL 8929 HAND PIECE | Medtronic, Inc. | 2010-05-21 | Special | PDF ↗ |
| K092309 | SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L | Olympus Medical Systems Corporation | 2009-10-30 | Traditional | PDF ↗ |
| K083292 | HABIB ENDOHPB | Emcision , Ltd. | 2009-06-10 | Traditional | PDF ↗ |
| K083275 | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 | Max Endoscopy, Inc. | 2009-06-09 | Traditional | PDF ↗ |
| K082114 | ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 | Apollo Endosurgery, Inc. | 2008-12-19 | Traditional | PDF ↗ |
| K082464 | PROSTIVA RF THERAPY HAND PIECE, MODEL 8929 | Medtronic, Inc. | 2008-10-27 | Traditional | PDF ↗ |
| K080946 | CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX | Conmed Endoscopic Technologies, Inc. | 2008-05-20 | Traditional | PDF ↗ |
| K072383 | HABIB ENDOBLATE | Emcision , Ltd. | 2007-11-29 | Traditional | PDF ↗ |
| K061684 | MEDI-GLOBE ROTA-CUT SPHINCTEROTOME | Medi-Globe Corporation | 2006-06-27 | Traditional | PDF ↗ |
| K052413 | TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 | Medtronic Vascular | 2005-11-17 | Traditional | PDF ↗ |
| K052051 | OMNI SPHINCTEROTOME | Wilson-Cook Medical, Inc. | 2005-08-05 | Special | PDF ↗ |
| K050578 | COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE | Cook Ireland, Ltd. | 2005-04-22 | Traditional | PDF ↗ |
| K033135 | STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM | Stryker Endoscopy | 2004-08-09 | Traditional | PDF ↗ |
| K040981 | USW NEEDLEKNIFE PAPILLOTOME | Wilson-Cook Medical, Inc. | 2004-05-07 | Special | PDF ↗ |
| K033203 | WILSON-COOK TRI-TOME SELECT PLUS | Wilson-Cook Medical, Inc. | 2003-12-19 | Traditional | PDF ↗ |
| K031026 | ETI BIPOLAR HEMOSTATIC PROBE | Endo-Therapeutics, Inc. | 2003-06-27 | Traditional | PDF ↗ |
| K030194 | XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT | The Olympus Optical Co. | 2003-03-24 | Traditional | PDF ↗ |
| K030315 | MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM | Ultroid, LLC | 2003-02-27 | Special | PDF ↗ |
| K023706 | ULTROID HEMORRHOID MANAGEMENT SYSTEM | Ultroid, LLC | 2003-01-14 | Traditional | PDF ↗ |
| K022595 | WILSON-COOK CYSTOTOME | Wilson-Cook Medical, Inc. | 2002-10-17 | Traditional | PDF ↗ |
| K021266 | ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018 | Ethicon Endo-Surgery, Inc. | 2002-09-27 | Traditional | PDF ↗ |
| K012587 | RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE | Vidamed, Inc. | 2001-12-11 | Traditional | PDF ↗ |
| K013153 | AUTOTOME RX MODEL # 4515, 4516 | Boston Scientific Corp | 2001-10-19 | Special | PDF ↗ |
| K011787 | PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE | Vidamed, Inc. | 2001-07-06 | Special | PDF ↗ |
| K010568 | ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM | Arthrocare Corp. | 2001-03-27 | Special | PDF ↗ |
| K002583 | TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM | Vidamed, Inc. | 2001-02-13 | Traditional | PDF ↗ |
| K002236 | HORIZONS PAPILLOTOME | Horizons Intl. Corp. | 2001-01-23 | Traditional | PDF ↗ |
| K003569 | PLASMAKINETIC ENDOUROLOGY SYSTEM | Gyrus Medical , Ltd. | 2000-12-19 | Special | PDF ↗ |
| K002802 | RAPID EXCHANGE TAPERTOME | Boston Scientific Corp | 2000-10-05 | Special | PDF ↗ |
| K000508 | THERMOFLEX SYSTEM | Argomed, Inc. | 2000-04-18 | Traditional | PDF ↗ |
| K994166 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE | Gyrus Medical , Ltd. | 1999-12-27 | Special | PDF ↗ |
| K992402 | 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 | Telemed Systems, Inc. | 1999-12-22 | Traditional | PDF ↗ |
| K991847 | THERMOFLEX SYSTEM | Argomed, Inc. | 1999-08-26 | Traditional | PDF ↗ |
| K990628 | GYRUS ENDOUROLOGY SYSTEM | Gyrus Medical , Ltd. | 1999-06-29 | Traditional | PDF ↗ |
Product code KNS · Class II · Gastroenterology, Urology. Data: openFDA.