K123911 is an FDA 510(k) clearance for the SENOMARK ULTRA BREAST TISSUE MARKER. This device is classified as a Marker, Radiographic, Implantable (Class II - Special Controls, product code NEU).
Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on January 10, 2013, 22 days after receiving the submission on December 19, 2012.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K123911 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2012 |
| Decision Date | January 10, 2013 |
| Days to Decision | 22 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 |