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
121–144 of 188
Cleared Jun 20, 1991
BIPROBE(TM)
K912601
C.R. Bard, Inc.
Gastroenterology & Urology · 10d
Cleared Oct 01, 1990
RESECTOSCOPE LOOPS
K903323
Olympus Corp.
Gastroenterology & Urology · 68d
Cleared Jun 18, 1990
ZIMMON PAPILLOTOME
K901443
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 83d
Cleared Feb 12, 1990
DOBBHOFF(R) PAPILLOTOME
K896612
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 83d
Cleared Jan 29, 1990
PORGES DIATHERMY SNARE
K896507
Porges Corp.
Gastroenterology & Urology · 75d
Cleared Jan 22, 1990
PORGES SPHINCTEROTOMES
K896426
Porges Corp.
Gastroenterology & Urology · 75d
Cleared Jan 11, 1990
BITOME(TM) BIPOLAR SPHINCTEROTOME
K895842
Everest Medical Corp.
Gastroenterology & Urology · 101d
Cleared Dec 21, 1989
WILTEK PAPILLOTOME
K894861
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Sep 25, 1989
MODEL 8800 BIPOLAR COAGULATION THERAPEUTIC SYSTEM
K892895
Everest Medical Corp.
Gastroenterology & Urology · 153d
Cleared Feb 01, 1989
MICROVASIVE GOLD PROBE
K885005
Boston Scientific Corp
Gastroenterology & Urology · 62d
Cleared Aug 04, 1988
BALL TIP FULGURATING ELECTRODE, 3 FRENCH
K880748
Cook Urological, Inc.
Gastroenterology & Urology · 162d
Cleared Apr 17, 1987
THERMAL COAGULATOR
K870705
Microvasive
Gastroenterology & Urology · 56d
Cleared Dec 09, 1986
MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE
K864413
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 29d
Cleared Oct 16, 1986
HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE
K861904
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 153d
Cleared Jul 22, 1986
ET/RT PAPILLOTOME
K860593
Hobbs Medical, Inc.
Gastroenterology & Urology · 153d
Cleared Jun 27, 1986
POLYPECTOMY SNARE
K862060
Endovations
Gastroenterology & Urology · 28d
Cleared Apr 07, 1986
CHALLENGER HOT BIOPSY FORCEPS
K860366
Microvasive
Gastroenterology & Urology · 63d
Cleared Nov 04, 1985
ENDODYNAMIC SIEGEL SPHINCTEROTOME
K853680
E-Z-Em, Inc.
Gastroenterology & Urology · 61d
Cleared Jul 25, 1985
ROTATABLE POLYPECTOMY SNARE POS-1
K851958
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 83d
Cleared Jun 24, 1985
PAPILLOTOME
K851652
Microvasive
Gastroenterology & Urology · 63d
Cleared Jun 13, 1985
E.R.C.P.-1 ENDOSCOPIC RETROGRADE CHOLANGIO-CATHETE
K851964
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 41d
Cleared May 22, 1985
HPU HEAT PROBE AUTOMATED ELECTROCAUTERY SYSTEM
K851096
Olympus Corp.
Gastroenterology & Urology · 64d
Cleared Jan 15, 1985
DAVOL PAPILLITOME
K845015
C.R. Bard, Inc.
Gastroenterology & Urology · 20d
Cleared Oct 18, 1984
INFRARED COAGULATOR
K842810
Endo Lase, Inc.
Gastroenterology & Urology · 92d