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.

189
Total
189
Cleared
106d
Avg days
1976
Since
189 devices
97–120 of 189
Cleared Dec 27, 1999
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
K994166
Gyrus Medical , Ltd.
Gastroenterology & Urology · 18d
Cleared Dec 22, 1999
5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH
K992402
Telemed Systems, Inc.
Gastroenterology & Urology · 156d
Cleared Aug 26, 1999
THERMOFLEX SYSTEM
K991847
Argomed, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 29, 1999
GYRUS ENDOUROLOGY SYSTEM
K990628
Gyrus Medical , Ltd.
Gastroenterology & Urology · 124d
Cleared Jun 11, 1999
COOPERSURGICAL INFRARED COAGULATOR
K990852
CooperSurgical, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 01, 1999
COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL
K990850
CooperSurgical, Inc.
Gastroenterology & Urology · 78d
Cleared May 03, 1999
BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME
K990376
Ballard Medical Products
Gastroenterology & Urology · 84d
Cleared Mar 30, 1999
COOPERSURGICAL INFRARED COAGULATOR FOR ENT
K990855
CooperSurgical, Inc.
Gastroenterology & Urology · 15d
Cleared Mar 25, 1999
WILSON-COOK BIPOLAR PROBE
K990145
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 65d
Cleared Sep 10, 1998
BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES
K982557
Bard Interventional Products Div.
Gastroenterology & Urology · 50d
Cleared Aug 19, 1998
HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##
K982289
Olympus America, Inc.
Gastroenterology & Urology · 50d
Cleared Jan 23, 1998
COOPERSURGICAL INFRARED COAGULATOR
K974168
Hogan & Hartson
Gastroenterology & Urology · 79d
Cleared Dec 05, 1997
SPHINCTEROTOME
K973826
Boston Scientific Corp
Gastroenterology & Urology · 59d
Cleared Nov 26, 1997
COBRA HAND PIECE
K973366
Vidamed, Inc.
Gastroenterology & Urology · 79d
Cleared Aug 15, 1997
WILSON-COOK NEEDLE KNIFE PAPILLOTOME
K972674
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 30d
Cleared May 07, 1997
ANGLED TIP POLYPECTOMY SNARE
K970945
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 54d
Cleared Apr 11, 1997
MICROVASIVE GOLD PROBE
K970278
Boston Scientific Corp
Gastroenterology & Urology · 78d
Cleared Mar 28, 1997
ULTRATOMERX
K970053
Boston Scientific Corp
Gastroenterology & Urology · 80d
Cleared Nov 19, 1996
BARD HIGH FLOW PAPILLOTOME
K963484
Bard Interventional Products Div.
Gastroenterology & Urology · 77d
Cleared Nov 01, 1996
KARL STORZ REMORGIDA FORCEPS
K962083
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 156d
Cleared Aug 08, 1996
PAPILLOTOME
K962346
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 51d
Cleared Jul 31, 1996
SPHINCTEROTOME
K960231
Lighthouse Medical, Inc.
Gastroenterology & Urology · 196d
Cleared Jul 22, 1996
REUSABLE ENDOSCOPIC ACCESSORY HANDLE
K961762
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 76d
Cleared May 15, 1996
INJECTION GOLD PROBE
K961349
Boston Scientific Corp
Gastroenterology & Urology · 37d