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
Cleared
Sep 21, 2022
MCB UNIT Model: V10GMCBUS
Lamidey Noury Medical
Gastroenterology & Urology
30d
Cleared
Jun 09, 2022
Cysto-Gastro-Sets
G-Flex Europe Sprl
Gastroenterology & Urology
353d
Cleared
Mar 21, 2022
Multi-Functional Electrosurgical Knife
Anrei Medical (Hangzhou) Co., Ltd.
Gastroenterology & Urology
182d
Cleared
Dec 17, 2021
RF Vapor System
Aqua Medical, Inc.
Gastroenterology & Urology
30d
Cleared
Dec 01, 2021
Sphincterotome / short-wire compatible, Sterile Sphincterotome
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology
247d
Cleared
May 27, 2021
Aqua Medical RF Vapor System
Aqua Medical, Inc.
Gastroenterology & Urology
30d
Cleared
Feb 05, 2021
Sphincterotome
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology
284d
Cleared
Dec 03, 2020
ORISE ProKnife
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)
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology
267d
Cleared
Mar 19, 2020
Creo Electrosurgical System with HS1 Hemostasis Accessory
Creo Medical, Ltd.
Gastroenterology & Urology
156d
Cleared
Jan 30, 2020
TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
Wilson-Cook Medical, Inc.
Gastroenterology & Urology
155d
Cleared
Dec 17, 2019
Single Use Balloon Dilator V (with knife)
Olympus Medical Systems Corp.
Gastroenterology & Urology
47d
Cleared
Aug 02, 2019
Rezum System
Nxthera (A Boston Scientific Company)
Gastroenterology & Urology
57d
Cleared
Jun 21, 2019
Aqua Medical RF Vapor System
Aqua Medical, Inc.
Gastroenterology & Urology
182d
Cleared
May 15, 2019
Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
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
Sumitomo Bakelite Co., Ltd.
Gastroenterology & Urology
43d
Cleared
Apr 11, 2019
ELRA Electrode
Starmed Co., Ltd.
Gastroenterology & Urology
283d
Cleared
Mar 25, 2019
Rezum Delivery Device, Rezum Generator
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
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology
261d
Cleared
Apr 17, 2018
Fusion OMNI Sphincterotome
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology
260d
Cleared
Mar 20, 2018
Habib EndoHPB
Emcision , Ltd.
Gastroenterology & Urology
57d
Cleared
Feb 27, 2018
Rezum System
Nxthera, Inc.
Gastroenterology & Urology
29d
Cleared
Jan 18, 2018
Barrx SB RFA Endoscopic Catheter
Covidien, LLC
Gastroenterology & Urology
62d
Cleared
Nov 17, 2017
Single Use Electrosurgical knife
Olympus Medical Systems Corp.
Gastroenterology & Urology
211d