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 Wilson-Cook Medical, Inc., Boston Scientific Corp and Boston Scientific Corporation.
188
Total
188
Cleared
106d
Avg days
1976
Since
188 devices
Cleared
Aug 17, 2017
Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory
Creo Medical, Ltd.
Gastroenterology & Urology
48d
Cleared
Aug 17, 2017
Zimmon Needle Knife Papillotome
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology
45d
Cleared
Jun 17, 2016
SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long
Sumitomo Bakelite Co., Ltd.
Gastroenterology & Urology
266d
Cleared
Mar 17, 2016
Rezum System
Nxthera, Inc.
Gastroenterology & Urology
30d
Cleared
Mar 02, 2016
Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
Olympus Medical Systems Corp.
Gastroenterology & Urology
30d
Cleared
Oct 08, 2015
Single Use Balloon Dilator V (with Knife)
Olympus Medical Systems Corp.
Gastroenterology & Urology
259d
Cleared
Aug 27, 2015
Rezum System
Nxthera, Inc.
Gastroenterology & Urology
155d
Cleared
Mar 31, 2015
SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)
Olympus Medical Systems Copr.
Gastroenterology & Urology
252d
Cleared
Apr 02, 2014
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
Boston Scientific Corporation
Gastroenterology & Urology
100d
Cleared
Jul 26, 2013
BARRX CHANNEL RFA ENDOSCOPIC CATHETER
Covidien, LLC
Gastroenterology & Urology
140d
Cleared
Apr 11, 2013
SINGLE USE PRELOADED SPHINCTEROTOME V
Olympus Medical Systems Corp.
Gastroenterology & Urology
238d
Cleared
Dec 14, 2012
GYRUS ACMI BICOAG HEMOSTASIS PROBE
Olympus Surgical Technologies America
Gastroenterology & Urology
49d
Cleared
Aug 17, 2012
TRUETOME
Boston Scientific Corp
Gastroenterology & Urology
23d
Cleared
Apr 14, 2011
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
Boston Scientific Corporation
Gastroenterology & Urology
15d
Cleared
Oct 20, 2010
GYRUS ACMI BIOCOAG PROBE
Gyrus Acmi, Inc.
Gastroenterology & Urology
425d
Cleared
Sep 07, 2010
MERIT BIPOLAR COAGULATION PROBE
Merit Medical Systems, Inc.
Gastroenterology & Urology
27d
Cleared
Aug 02, 2010
TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U
Hobbs Medical, Inc.
Gastroenterology & Urology
306d
Cleared
May 21, 2010
PROSTIVA RF THERAPY MODEL 8929 HAND PIECE
Medtronic, Inc.
Gastroenterology & Urology
29d
Cleared
Oct 30, 2009
SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L
Olympus Medical Systems Corporation
Gastroenterology & Urology
92d
Cleared
Oct 27, 2008
PROSTIVA RF THERAPY HAND PIECE, MODEL 8929
Medtronic, Inc.
Gastroenterology & Urology
61d
Cleared
Nov 17, 2005
TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
Medtronic Vascular
Gastroenterology & Urology
76d
Cleared
Aug 05, 2005
OMNI SPHINCTEROTOME
Wilson-Cook Medical, Inc.
Gastroenterology & Urology
7d
Cleared
Apr 22, 2005
COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
Cook Ireland, Ltd.
Gastroenterology & Urology
46d
Cleared
Aug 09, 2004
STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM
Stryker Endoscopy
Gastroenterology & Urology
314d