K142125 is an FDA 510(k) clearance for the New Medax Biopsy Systems. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Medax Srl Unipersonale (Poggio Rusco, IT). The FDA issued a Cleared decision on December 22, 2015, 505 days after receiving the submission on August 4, 2014.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K142125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2014 |
| Decision Date | December 22, 2015 |
| Days to Decision | 505 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNW - Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |