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 Micro-Tech (Nanjing) Co., Ltd., Fujifilm Corporation and Olympus Medical Systems Corporation.

4
Total
4
Cleared
189d
Avg days
2021
Since