ClearanceBrief
Panels › Gastroenterology, Urology › Product code KNS · Class 2

Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Regulation 876.4300

4510(k)s in 12 months (189 all time)
43recalls in 12 months (125 all time)
122recalls that name a 510(k)
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Top companies in KNS

Company510(k)sRecalls
Boston Scientific1856
Olympus Corporation of the Americas039
Wilson-Cook Medical123
Aomori Olympus Co., Ltd.010
Olympus Medical Systems Corp.100
Olympus America, Inc.33
Aqua Medical, Inc.50
Creo Medical, Ltd.50
Mr Associates, Inc.50
Circon Acmi40
Decided510(k)Device and applicantCode
Sep 3, 2026K262460Rezum System
Boston Scientific
KNS
May 21, 2026K260962Sphincterotome
Taewoong Medical Co., Ltd., KR
KNS
Nov 26, 2025K252388Vanquish Water Vapor Ablation Device
Francis Medical, Inc.
KNS
Nov 25, 2025K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
Olympus Medical Systems Corporation, JP
KNS
Oct 17, 2025K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire G
Olympus Medical Systems Corp., JP
KNS
Oct 10, 2025K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurg
Olympus Medical Systems Corporation, JP
KNS
Sep 29, 2025K251104SureTome™ SW Sphincterotome with DomeTip
Wilson-Cook Medical
KNS
Aug 8, 2025K251226Aqua Medical RF Vapor Ablation System
Aqua Medical, Inc.
KNS
Jun 11, 2025K250584Rezum System
Boston Scientific Corporation
KNS
Jun 6, 2025K242774SpydrBlade Flex Instrument (PRD-RG1-001)
Creo Medical, Ltd., GB
KNS
Mar 26, 2025K241855SB Knife Jr2 (MD-47702 and MD-47702L)
Sb-Kawasumi Laboratories, Inc., JP
KNS
Feb 6, 2025K242192Disposable Sphincterotome
Beijing Zksk Technology Co., Ltd., CN
KNS
Jan 17, 2025K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
Wilson-Cook Medical, Inc.
KNS
Dec 12, 2024K241271Aqua Medical RF Vapor Ablation System
Aqua Medical, Inc.
KNS
Aug 15, 2024K242061Reusable Interface Cable 1.5 m (PRD-IFC-002)
Creo Medical, Ltd., GB
KNS
Mar 29, 2024K232825Disposable Sphincterotome
Jiangsu Vedkang Medical Science and Technology Co., Ltd., CN
KNS
Nov 28, 2023K232633Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter
Boston Scientific
KNS
Nov 7, 2023K232476Disposable Sphincterotome
Zhejiang Soudon Medical Technology Co., Ltd., CN
KNS
Oct 31, 2023K230328Speedboat Flush SB1 Instrument
Creo Medical, Ltd., GB
KNS
Oct 27, 2023K233318AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery Syst
Boston Scientific Corporation
KNS
Oct 25, 2023K233113ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)
Starmed Co., Ltd., KR
KNS
Aug 14, 2023K232162Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 3
Boston Scientific Corporation
KNS
Jun 21, 2023K231533Habib EndoHPB
Boston Scientific Corporation
KNS
May 3, 2023K222421Sphincterotome
Hangzhou AGS MedTech Co., Ltd., CN
KNS
Apr 5, 2023K223256Optimos™ Cystotome
Taewoong Medical Co., Ltd., KR
KNS
Sep 21, 2022K222542MCB UNIT Model: V10GMCBUS
Lamidey Noury Medical, FR
KNS
Jun 9, 2022K211909Cysto-Gastro-Sets
G-Flex Europe Sprl, BE
KNS
Mar 21, 2022K212999Multi-Functional Electrosurgical Knife
Anrei Medical (Hangzhou) Co., Ltd., CN
KNS
Dec 17, 2021K213627RF Vapor System
Aqua Medical, Inc.
KNS
Dec 1, 2021K210934Sphincterotome / short-wire compatible, Sterile Sphincterotome
Micro-Tech (Nanjing) Co., Ltd., CN
KNS
May 27, 2021K211282Aqua Medical RF Vapor System
Aqua Medical, Inc.
KNS
Feb 5, 2021K201121Sphincterotome
Hangzhou AGS MedTech Co., Ltd., CN
KNS
Dec 3, 2020K200404ORISE ProKnife
Boston Scientific Corporation
KNS
May 21, 2020K192342Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgi
Hangzhou AGS MedTech Co., Ltd., CN
KNS
Mar 19, 2020K192905Creo Electrosurgical System with HS1 Hemostasis Accessory
Creo Medical, Ltd., GB
KNS
Jan 30, 2020K192339TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
Wilson-Cook Medical, Inc.
KNS
Dec 17, 2019K193039Single Use Balloon Dilator V (with knife)
Olympus Medical Systems Corp., JP
KNS
Aug 2, 2019K191505Rezum System
Nxthera (A Boston Scientific Company)
KNS
Jun 21, 2019K183595Aqua Medical RF Vapor System
Aqua Medical, Inc.
KNS
May 15, 2019K182408Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
Olympus Medical Systems Corp., JP
KNS
Apr 23, 2019K190621SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long
Sumitomo Bakelite Co., Ltd., JP
KNS
Apr 11, 2019K181758ELRA Electrode
Starmed Co., Ltd., KR
KNS
Mar 25, 2019K190093Rezum Delivery Device, Rezum Generator
Nxthera (A Boston Scientific Company)
KNS
May 24, 2018K172665Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sp
Wilson-Cook Medical Inc./Cook Endoscopy
KNS
Apr 17, 2018K172288Fusion OMNI Sphincterotome
Wilson-Cook Medical Inc./Cook Endoscopy
KNS
Mar 20, 2018K180165Habib EndoHPB
Emcision , Ltd., GB
KNS
Feb 27, 2018K180237Rezum System
Nxthera, Inc.
KNS
Jan 18, 2018K173559Barrx SB RFA Endoscopic Catheter
Covidien, LLC
KNS
Nov 17, 2017K171158Single Use Electrosurgical knife
Olympus Medical Systems Corp., JP
KNS
Aug 17, 2017K171993Zimmon Needle Knife Papillotome
Wilson-Cook Medical Inc./Cook Endoscopy
KNS

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