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
May 07, 2004
USW NEEDLEKNIFE PAPILLOTOME
Wilson-Cook Medical, Inc.
Gastroenterology & Urology
22d
Cleared
Dec 19, 2003
WILSON-COOK TRI-TOME SELECT PLUS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology
78d
Cleared
Mar 24, 2003
XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
The Olympus Optical Co.
Gastroenterology & Urology
62d
Cleared
Oct 17, 2002
WILSON-COOK CYSTOTOME
Wilson-Cook Medical, Inc.
Gastroenterology & Urology
73d
Cleared
Sep 27, 2002
ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology
158d
Cleared
Oct 19, 2001
AUTOTOME RX MODEL # 4515, 4516
Boston Scientific Corp
Gastroenterology & Urology
29d
Cleared
Mar 27, 2001
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
Arthrocare Corp.
Gastroenterology & Urology
29d
Cleared
Oct 05, 2000
RAPID EXCHANGE TAPERTOME
Boston Scientific Corp
Gastroenterology & Urology
27d
Cleared
Dec 27, 1999
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
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
Telemed Systems, Inc.
Gastroenterology & Urology
156d
Cleared
Aug 26, 1999
THERMOFLEX SYSTEM
Argomed, Inc.
Gastroenterology & Urology
90d
Cleared
Jun 29, 1999
GYRUS ENDOUROLOGY SYSTEM
Gyrus Medical , Ltd.
Gastroenterology & Urology
124d
Cleared
Jun 11, 1999
COOPERSURGICAL INFRARED COAGULATOR
CooperSurgical, Inc.
Gastroenterology & Urology
88d
Cleared
Jun 01, 1999
COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL
CooperSurgical, Inc.
Gastroenterology & Urology
78d
Cleared
May 03, 1999
BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME
Ballard Medical Products
Gastroenterology & Urology
84d
Cleared
Mar 30, 1999
COOPERSURGICAL INFRARED COAGULATOR FOR ENT
CooperSurgical, Inc.
Gastroenterology & Urology
15d
Cleared
Mar 25, 1999
WILSON-COOK BIPOLAR PROBE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology
65d
Cleared
Sep 10, 1998
BARD PROFORMA AND APOLLO PRE-CURVED PAPILLOTOMES
Bard Interventional Products Div.
Gastroenterology & Urology
50d
Cleared
Aug 19, 1998
HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##
Olympus America, Inc.
Gastroenterology & Urology
50d
Cleared
Jan 23, 1998
COOPERSURGICAL INFRARED COAGULATOR
Hogan & Hartson
Gastroenterology & Urology
79d
Cleared
Dec 05, 1997
SPHINCTEROTOME
Boston Scientific Corp
Gastroenterology & Urology
59d
Cleared
Nov 26, 1997
COBRA HAND PIECE
Vidamed, Inc.
Gastroenterology & Urology
79d
Cleared
Aug 15, 1997
WILSON-COOK NEEDLE KNIFE PAPILLOTOME
Wilson-Cook Medical, Inc.
Gastroenterology & Urology
30d
Cleared
May 07, 1997
ANGLED TIP POLYPECTOMY SNARE
United States Endoscopy Group, Inc.
Gastroenterology & Urology
54d