KGE · Class II · 21 CFR 876.4300

FDA Product Code KGE: Forceps, Biopsy, Electric

Electrosurgical biopsy forceps combine tissue sampling with hemostasis in a single instrument. FDA product code KGE covers electric biopsy forceps used during gastrointestinal endoscopy.

These forceps apply electrical current to coagulate the tissue before or after biopsy, reducing bleeding risk in highly vascular lesions. They are used for polyp sampling, tumor biopsy, and treatment of vascular lesions in the GI tract.

KGE 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., Micro-Tech (Nanjing) Co., Ltd. and Olympus Medical Systems Corp..

46
Total
46
Cleared
141d
Avg days
1989
Since
46 devices
25–46 of 46
Cleared Sep 18, 1997
RESUABLE HOT BIOPSY FORCEPS
K972505
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 17, 1997
DYNABITE HOT GI BIOPSY FORCEPS
K970083
Portlyn Corp.
Gastroenterology & Urology · 159d
Cleared May 27, 1997
LSVP INTERNATIONAL HOT BIOPSY FORCEPS
K971204
Lsvp Intl., Inc.
Gastroenterology & Urology · 56d
Cleared Apr 04, 1996
GIP/MEID-GLOBE HOT BIOPSY FORCEPS
K953355
Medi-Globe Corp.
Gastroenterology & Urology · 262d
Cleared Jan 24, 1996
OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS
K955052
Olympus America, Inc.
Gastroenterology & Urology · 79d
Cleared May 03, 1995
OLYMPUS FD-5 HOT BIOPSY FORCEPS
K951445
Olympus America, Inc.
Gastroenterology & Urology · 35d
Cleared Mar 28, 1995
KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS
K944765
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 182d
Cleared Nov 14, 1994
HOT BIOPSY FORCEPS
K943078
Intl. Medical, Inc.
Gastroenterology & Urology · 139d
Cleared Mar 15, 1994
SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN
K932266
Symbiosis Corp.
Gastroenterology & Urology · 329d
Cleared Apr 21, 1993
DISPOSABLE HOT BIOPSY FORCEPS
K923470
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 281d
Cleared Mar 29, 1993
BIOPSY FORCEPS, ELECTRIC
K925361
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 158d
Cleared May 02, 1991
HOT BIOPSY FORCEPS
K910964
Symbiosis Corp.
Gastroenterology & Urology · 57d
Cleared Jan 25, 1991
BIPOLAR BIOPSY FORCEPS
K904985
Everest Medical Corp.
Gastroenterology & Urology · 84d
Cleared Nov 30, 1989
PORGES HOT BIOPSY FORCEPS
K896537
Porges Corp.
Gastroenterology & Urology · 15d