K133697 is an FDA 510(k) clearance for the BREAST-MED TISSUE MARKER. This device is classified as a Marker, Radiographic, Implantable (Class II - Special Controls, product code NEU).
Submitted by Breast-Med, Inc. (Golden Valley, US). The FDA issued a Cleared decision on April 10, 2015, 493 days after receiving the submission on December 3, 2013.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K133697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2013 |
| Decision Date | April 10, 2015 |
| Days to Decision | 493 days |
| Submission Type | Traditional |
| 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 |