K955065 is an FDA 510(k) clearance for the OLYMPUS FB SERIES BIOPSY FORCEPS, a Forceps, Biopsy, Non-electric (Class I — General Controls, product code FCL), submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on January 24, 1996, 79 days after receiving the submission on November 6, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K955065 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 06, 1995 |
| Decision Date | January 24, 1996 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCL — Forceps, Biopsy, Non-electric |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.1075 |