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 Wilson-Cook Medical, Inc., Boston Scientific Corp and Boston Scientific Corporation.

188
Total
188
Cleared
106d
Avg days
1976
Since
188 devices
49–72 of 188
Cleared Aug 17, 2017
Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory
K171983
Creo Medical, Ltd.
Gastroenterology & Urology · 48d
Cleared Aug 17, 2017
Zimmon Needle Knife Papillotome
K171993
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
K152771
Sumitomo Bakelite Co., Ltd.
Gastroenterology & Urology · 266d
Cleared Mar 17, 2016
Rezum System
K160417
Nxthera, Inc.
Gastroenterology & Urology · 30d
Cleared Mar 02, 2016
Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
K160241
Olympus Medical Systems Corp.
Gastroenterology & Urology · 30d
Cleared Oct 08, 2015
Single Use Balloon Dilator V (with Knife)
K150142
Olympus Medical Systems Corp.
Gastroenterology & Urology · 259d
Cleared Aug 27, 2015
Rezum System
K150786
Nxthera, Inc.
Gastroenterology & Urology · 155d
Cleared Mar 31, 2015
SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)
K141991
Olympus Medical Systems Copr.
Gastroenterology & Urology · 252d
Cleared Apr 02, 2014
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K133933
Boston Scientific Corporation
Gastroenterology & Urology · 100d
Cleared Jul 26, 2013
BARRX CHANNEL RFA ENDOSCOPIC CATHETER
K130623
Covidien, LLC
Gastroenterology & Urology · 140d
Cleared Apr 11, 2013
SINGLE USE PRELOADED SPHINCTEROTOME V
K122505
Olympus Medical Systems Corp.
Gastroenterology & Urology · 238d
Cleared Dec 14, 2012
GYRUS ACMI BICOAG HEMOSTASIS PROBE
K123319
Olympus Surgical Technologies America
Gastroenterology & Urology · 49d
Cleared Aug 17, 2012
TRUETOME
K122203
Boston Scientific Corp
Gastroenterology & Urology · 23d
Cleared Apr 14, 2011
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K110887
Boston Scientific Corporation
Gastroenterology & Urology · 15d
Cleared Oct 20, 2010
GYRUS ACMI BIOCOAG PROBE
K092571
Gyrus Acmi, Inc.
Gastroenterology & Urology · 425d
Cleared Sep 07, 2010
MERIT BIPOLAR COAGULATION PROBE
K102273
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
K093079
Hobbs Medical, Inc.
Gastroenterology & Urology · 306d
Cleared May 21, 2010
PROSTIVA RF THERAPY MODEL 8929 HAND PIECE
K101139
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
K092309
Olympus Medical Systems Corporation
Gastroenterology & Urology · 92d
Cleared Oct 27, 2008
PROSTIVA RF THERAPY HAND PIECE, MODEL 8929
K082464
Medtronic, Inc.
Gastroenterology & Urology · 61d
Cleared Nov 17, 2005
TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
K052413
Medtronic Vascular
Gastroenterology & Urology · 76d
Cleared Aug 05, 2005
OMNI SPHINCTEROTOME
K052051
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 7d
Cleared Apr 22, 2005
COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
K050578
Cook Ireland, Ltd.
Gastroenterology & Urology · 46d
Cleared Aug 09, 2004
STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM
K033135
Stryker Endoscopy
Gastroenterology & Urology · 314d