K103359 is an FDA 510(k) clearance for the FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK). This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on December 27, 2010, 41 days after receiving the submission on November 16, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K103359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2010 |
| Decision Date | December 27, 2010 |
| Days to Decision | 41 days |
| Submission Type | Special |
| 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 |