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
73–96 of 189
Cleared May 20, 2008
CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
K080946
Conmed Endoscopic Technologies, Inc.
Gastroenterology & Urology · 47d
Cleared Nov 29, 2007
HABIB ENDOBLATE
K072383
Emcision , Ltd.
Gastroenterology & Urology · 97d
Cleared Jun 27, 2006
MEDI-GLOBE ROTA-CUT SPHINCTEROTOME
K061684
Medi-Globe Corporation
Gastroenterology & Urology · 12d
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
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 Jun 27, 2003
ETI BIPOLAR HEMOSTATIC PROBE
K031026
Endo-Therapeutics, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 24, 2003
XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
K030194
The Olympus Optical Co.
Gastroenterology & Urology · 62d
Cleared Feb 27, 2003
MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
K030315
Ultroid, LLC
Gastroenterology & Urology · 28d
Cleared Jan 14, 2003
ULTROID HEMORRHOID MANAGEMENT SYSTEM
K023706
Ultroid, LLC
Gastroenterology & Urology · 71d
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 Dec 11, 2001
RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE
K012587
Vidamed, Inc.
Gastroenterology & Urology · 123d
Cleared Oct 19, 2001
AUTOTOME RX MODEL # 4515, 4516
K013153
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Jul 06, 2001
PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE
K011787
Vidamed, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 27, 2001
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
K010568
Arthrocare Corp.
Gastroenterology & Urology · 29d
Cleared Feb 13, 2001
TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM
K002583
Vidamed, Inc.
Gastroenterology & Urology · 179d
Cleared Jan 23, 2001
HORIZONS PAPILLOTOME
K002236
Horizons Intl. Corp.
Gastroenterology & Urology · 183d
Cleared Dec 19, 2000
PLASMAKINETIC ENDOUROLOGY SYSTEM
K003569
Gyrus Medical , Ltd.
Gastroenterology & Urology · 29d
Cleared Oct 05, 2000
RAPID EXCHANGE TAPERTOME
K002802
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Apr 18, 2000
THERMOFLEX SYSTEM
K000508
Argomed, Inc.
Gastroenterology & Urology · 63d