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 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 Aug 19, 1998
HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##
K982289
Olympus America, Inc.
Gastroenterology & Urology · 50d
Cleared Dec 05, 1997
SPHINCTEROTOME
K973826
Boston Scientific Corp
Gastroenterology & Urology · 59d
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
Cleared Apr 11, 1997
MICROVASIVE GOLD PROBE
K970278
Boston Scientific Corp
Gastroenterology & Urology · 78d
Cleared Mar 28, 1997
ULTRATOMERX
K970053
Boston Scientific Corp
Gastroenterology & Urology · 80d
Cleared Nov 01, 1996
KARL STORZ REMORGIDA FORCEPS
K962083
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 156d
Cleared Aug 08, 1996
PAPILLOTOME
K962346
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 51d
Cleared Jul 22, 1996
REUSABLE ENDOSCOPIC ACCESSORY HANDLE
K961762
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 76d
Cleared May 15, 1996
INJECTION GOLD PROBE
K961349
Boston Scientific Corp
Gastroenterology & Urology · 37d
Cleared Apr 30, 1996
OLYMPUS KD SERIES SPHINCTEROTOME
K955247
Olympus America, Inc.
Gastroenterology & Urology · 167d
Cleared Nov 21, 1995
CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS
K946109
Cabot Medical Corp.
Gastroenterology & Urology · 342d
Cleared Feb 22, 1995
OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE
K950166
Olympus America, Inc.
Gastroenterology & Urology · 36d
Cleared Jan 30, 1995
HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP
K945764
Aaron Medical Industries
Gastroenterology & Urology · 90d
Cleared Nov 09, 1994
AESCULAP THORACOSCOPIC INSTRUMENTS
K944955
Aesculap, Inc.
Gastroenterology & Urology · 33d
Cleared Nov 02, 1994
MICROVASIVE INJECTION GOLD PROBE
K942301
Boston Scientific Corp
Gastroenterology & Urology · 174d
Cleared Jul 27, 1994
CABOT MEDICAL BIPOLAR CUTTING FORCEPS
K932293
Cabot Medical Corp.
Gastroenterology & Urology · 442d
Cleared Feb 28, 1994
ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME
K934315
Endovations
Gastroenterology & Urology · 180d
Cleared May 06, 1992
DOBBHOFF BIPOLAR ADAPTER
K921029
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 64d
Cleared Mar 11, 1992
BIPOLAR ENDOSTASIS PROBE, BEST (TM)
K915408
Medical Devices, Inc.
Gastroenterology & Urology · 100d
Cleared Aug 07, 1991
DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE
K912129
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 85d
Cleared Jun 20, 1991
BIPROBE(TM)
K912601
C.R. Bard, Inc.
Gastroenterology & Urology · 10d