K954151 is an FDA 510(k) clearance for the BIOACCESS BONE BIOPSY SYSTEM. This device is classified as a Instrument, Biopsy (Class II — Special Controls, product code KNW).
Submitted by Bioaccess, Inc. (Silver Spring, US). The FDA issued a Cleared decision on September 15, 1995, 10 days after receiving the submission on September 5, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K954151 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 05, 1995 |
| Decision Date | September 15, 1995 |
| Days to Decision | 10 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 |