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
73–96 of 188
Cleared May 07, 2004
USW NEEDLEKNIFE PAPILLOTOME
K040981
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 22d
Cleared Dec 19, 2003
WILSON-COOK TRI-TOME SELECT PLUS
K033203
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 78d
Cleared Mar 24, 2003
XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
K030194
The Olympus Optical Co.
Gastroenterology & Urology · 62d
Cleared Oct 17, 2002
WILSON-COOK CYSTOTOME
K022595
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 73d
Cleared Sep 27, 2002
ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018
K021266
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 158d
Cleared Oct 19, 2001
AUTOTOME RX MODEL # 4515, 4516
K013153
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Mar 27, 2001
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
K010568
Arthrocare Corp.
Gastroenterology & Urology · 29d
Cleared Oct 05, 2000
RAPID EXCHANGE TAPERTOME
K002802
Boston Scientific Corp
Gastroenterology & Urology · 27d
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