K130616 is an FDA 510(k) clearance for the MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Biopsybell S.R.L. (Verona, US). The FDA issued a Cleared decision on February 7, 2014, 337 days after receiving the submission on March 7, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K130616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2013 |
| Decision Date | February 07, 2014 |
| Days to Decision | 337 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 |