K953880 is an FDA 510(k) clearance for the BIOPSY NEEDLE, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Biopsys Medical, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on September 8, 1995, 21 days after receiving the submission on August 18, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K953880 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 18, 1995 |
| Decision Date | September 08, 1995 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1075 |