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 Boston Scientific Corp, Boston Scientific Corporation and Aqua Medical, Inc..

188
Total
188
Cleared
106d
Avg days
1976
Since
188 devices
49–72 of 188
Cleared Apr 02, 2014
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K133933
Boston Scientific Corporation
Gastroenterology & Urology · 100d
Cleared Aug 17, 2012
TRUETOME
K122203
Boston Scientific Corp
Gastroenterology & Urology · 23d
Cleared Apr 14, 2011
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K110887
Boston Scientific Corporation
Gastroenterology & Urology · 15d
Cleared Nov 17, 2005
TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
K052413
Medtronic Vascular
Gastroenterology & Urology · 76d
Cleared Oct 19, 2001
AUTOTOME RX MODEL # 4515, 4516
K013153
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Oct 05, 2000
RAPID EXCHANGE TAPERTOME
K002802
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Dec 05, 1997
SPHINCTEROTOME
K973826
Boston Scientific Corp
Gastroenterology & Urology · 59d
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 May 15, 1996
INJECTION GOLD PROBE
K961349
Boston Scientific Corp
Gastroenterology & Urology · 37d
Cleared Nov 02, 1994
MICROVASIVE INJECTION GOLD PROBE
K942301
Boston Scientific Corp
Gastroenterology & Urology · 174d
Cleared Jun 20, 1991
BIPROBE(TM)
K912601
C.R. Bard, Inc.
Gastroenterology & Urology · 10d
Cleared Feb 01, 1989
MICROVASIVE GOLD PROBE
K885005
Boston Scientific Corp
Gastroenterology & Urology · 62d
Cleared Jan 15, 1985
DAVOL PAPILLITOME
K845015
C.R. Bard, Inc.
Gastroenterology & Urology · 20d