K152989 is an FDA 510(k) clearance for the Mammotome revolve Dual Vacuum Assist Biopsy System, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Devicor Medical Products, Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 25, 2016, 135 days after receiving the submission on October 13, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K152989 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 13, 2015 |
| Decision Date | February 25, 2016 |
| Days to Decision | 135 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 |