K112411 is an FDA 510(k) clearance for the MAMMOTOME ELITE 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 March 20, 2012, 211 days after receiving the submission on August 22, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K112411 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 22, 2011 |
| Decision Date | March 20, 2012 |
| Days to Decision | 211 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 |