K946238 is an FDA 510(k) clearance for the SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS. This device is classified as a Forceps, Biopsy, Non-electric (Class I - General Controls, product code FCL).
Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on January 20, 1995, 29 days after receiving the submission on December 22, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K946238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1994 |
| Decision Date | January 20, 1995 |
| Days to Decision | 29 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 |