K972505 is an FDA 510(k) clearance for the RESUABLE HOT BIOPSY FORCEPS. 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 September 18, 1997, 77 days after receiving the submission on July 3, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K972505 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 1997 |
| Decision Date | September 18, 1997 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KGE - Forceps, Biopsy, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |