K111692 is an FDA 510(k) clearance for the TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC. This device is classified as a Marker, Radiographic, Implantable (Class II - Special Controls, product code NEU).
Submitted by Somatex Medical Technologies GmbH (Wurmlingen, DE). The FDA issued a Cleared decision on November 8, 2011, 145 days after receiving the submission on June 16, 2011.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K111692 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2011 |
| Decision Date | November 08, 2011 |
| Days to Decision | 145 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEU - Marker, Radiographic, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |