K902461 is an FDA 510(k) clearance for the MEADOX SURGIMED BIOPSY GUN AND NEEDLE. 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 July 16, 1990, 42 days after receiving the submission on June 4, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K902461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 1990 |
| Decision Date | July 16, 1990 |
| Days to Decision | 42 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 |