K962425 is an FDA 510(k) clearance for the BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4), a Needle, Aspiration And Injection, Disposable (Class I — General Controls, product code GAA), submitted by Radi Medical Systems AB (Uppsala, SE). The FDA issued a Cleared decision on September 11, 1996, 79 days after receiving the submission on June 24, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K962425 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 24, 1996 |
| Decision Date | September 11, 1996 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAA — Needle, Aspiration And Injection, Disposable |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |