K932266 is an FDA 510(k) clearance for the SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN. This device is classified as a Forceps, Biopsy, Electric (Class II - Special Controls, product code KGE).
Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on March 15, 1994, 329 days after receiving the submission on April 20, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K932266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 1993 |
| Decision Date | March 15, 1994 |
| Days to Decision | 329 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 |