K925361 is an FDA 510(k) clearance for the BIOPSY FORCEPS, ELECTRIC. This device is classified as a Forceps, Biopsy, Electric (Class II - Special Controls, product code KGE).
Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on March 29, 1993, 158 days after receiving the submission on October 22, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K925361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 1992 |
| Decision Date | March 29, 1993 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KGE - Forceps, Biopsy, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |