K911635 is an FDA 510(k) clearance for the MEADOX(R) SURGIMED(R) BIOPSY GUN II. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on June 20, 1991, 70 days after receiving the submission on April 11, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K911635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 1991 |
| Decision Date | June 20, 1991 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |