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
Cleared
May 20, 2008
CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
Conmed Endoscopic Technologies, Inc.
Gastroenterology & Urology
47d
Cleared
Nov 29, 2007
HABIB ENDOBLATE
Emcision , Ltd.
Gastroenterology & Urology
97d
Cleared
Jun 27, 2006
MEDI-GLOBE ROTA-CUT SPHINCTEROTOME
Medi-Globe Corporation
Gastroenterology & Urology
12d
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
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
Jun 27, 2003
ETI BIPOLAR HEMOSTATIC PROBE
Endo-Therapeutics, Inc.
Gastroenterology & Urology
88d
Cleared
Mar 24, 2003
XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
The Olympus Optical Co.
Gastroenterology & Urology
62d
Cleared
Feb 27, 2003
MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
Ultroid, LLC
Gastroenterology & Urology
28d
Cleared
Jan 14, 2003
ULTROID HEMORRHOID MANAGEMENT SYSTEM
Ultroid, LLC
Gastroenterology & Urology
71d
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
Dec 11, 2001
RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE
Vidamed, Inc.
Gastroenterology & Urology
123d
Cleared
Oct 19, 2001
AUTOTOME RX MODEL # 4515, 4516
Boston Scientific Corp
Gastroenterology & Urology
29d
Cleared
Jul 06, 2001
PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE
Vidamed, Inc.
Gastroenterology & Urology
28d
Cleared
Mar 27, 2001
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
Arthrocare Corp.
Gastroenterology & Urology
29d
Cleared
Feb 13, 2001
TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM
Vidamed, Inc.
Gastroenterology & Urology
179d
Cleared
Jan 23, 2001
HORIZONS PAPILLOTOME
Horizons Intl. Corp.
Gastroenterology & Urology
183d
Cleared
Dec 19, 2000
PLASMAKINETIC ENDOUROLOGY SYSTEM
Gyrus Medical , Ltd.
Gastroenterology & Urology
29d
Cleared
Oct 05, 2000
RAPID EXCHANGE TAPERTOME
Boston Scientific Corp
Gastroenterology & Urology
27d
Cleared
Apr 18, 2000
THERMOFLEX SYSTEM
Argomed, Inc.
Gastroenterology & Urology
63d