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 Olympus Medical Systems Corporation, Olympus Medical Systems Corp. and Micro-Tech (Nanjing) Co., Ltd..
FDA 510(k) Cleared Forceps, Biopsy, Electric Devices (Product Code KGE)
About Product Code KGE - Regulatory Context
510(k) Submission Activity
46 total 510(k) submissions under product code KGE since 1989, with 46 receiving FDA clearance (average review time: 141 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under KGE have taken an average of 256 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.
KGE devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →