KNS · Class II · 21 CFR 876.4300

FDA Product Code KNS: Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

FDA product code KNS covers endoscopic electrosurgical units used for cutting and coagulation during gastrointestinal endoscopy.

These systems deliver high-frequency electrical current through endoscopic accessories — including snares, forceps, and knives — to resect polyps, cut tissue, and control bleeding during procedures such as polypectomy, endoscopic mucosal resection, and sphincterotomy.

KNS devices are Class II medical devices, regulated under 21 CFR 876.4300 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Boston Scientific Corp, Boston Scientific Corporation and Aqua Medical, Inc..

188
Total
188
Cleared
106d
Avg days
1976
Since
188 devices
25–48 of 188
Cleared Sep 21, 2022
MCB UNIT Model: V10GMCBUS
K222542
Lamidey Noury Medical
Gastroenterology & Urology · 30d
Cleared Jun 09, 2022
Cysto-Gastro-Sets
K211909
G-Flex Europe Sprl
Gastroenterology & Urology · 353d
Cleared Mar 21, 2022
Multi-Functional Electrosurgical Knife
K212999
Anrei Medical (Hangzhou) Co., Ltd.
Gastroenterology & Urology · 182d
Cleared Dec 17, 2021
RF Vapor System
K213627
Aqua Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 01, 2021
Sphincterotome / short-wire compatible, Sterile Sphincterotome
K210934
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 247d
Cleared May 27, 2021
Aqua Medical RF Vapor System
K211282
Aqua Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 05, 2021
Sphincterotome
K201121
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 284d
Cleared Dec 03, 2020
ORISE ProKnife
K200404
Boston Scientific Corporation
Gastroenterology & Urology · 288d
Cleared May 21, 2020
Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)
K192342
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 267d
Cleared Mar 19, 2020
Creo Electrosurgical System with HS1 Hemostasis Accessory
K192905
Creo Medical, Ltd.
Gastroenterology & Urology · 156d
Cleared Jan 30, 2020
TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
K192339
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 155d
Cleared Dec 17, 2019
Single Use Balloon Dilator V (with knife)
K193039
Olympus Medical Systems Corp.
Gastroenterology & Urology · 47d
Cleared Aug 02, 2019
Rezum System
K191505
Nxthera (A Boston Scientific Company)
Gastroenterology & Urology · 57d
Cleared Jun 21, 2019
Aqua Medical RF Vapor System
K183595
Aqua Medical, Inc.
Gastroenterology & Urology · 182d
Cleared May 15, 2019
Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
K182408
Olympus Medical Systems Corp.
Gastroenterology & Urology · 253d
Cleared Apr 23, 2019
SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long
K190621
Sumitomo Bakelite Co., Ltd.
Gastroenterology & Urology · 43d
Cleared Apr 11, 2019
ELRA Electrode
K181758
Starmed Co., Ltd.
Gastroenterology & Urology · 283d
Cleared Mar 25, 2019
Rezum Delivery Device, Rezum Generator
K190093
Nxthera (A Boston Scientific Company)
Gastroenterology & Urology · 66d
Cleared May 24, 2018
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
Gastroenterology & Urology · 261d
Cleared Apr 17, 2018
Fusion OMNI Sphincterotome
K172288
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology · 260d
Cleared Mar 20, 2018
Habib EndoHPB
K180165
Emcision , Ltd.
Gastroenterology & Urology · 57d
Cleared Feb 27, 2018
Rezum System
K180237
Nxthera, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 18, 2018
Barrx SB RFA Endoscopic Catheter
K173559
Covidien, LLC
Gastroenterology & Urology · 62d
Cleared Nov 17, 2017
Single Use Electrosurgical knife
K171158
Olympus Medical Systems Corp.
Gastroenterology & Urology · 211d