K121964 is an FDA 510(k) clearance for the MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML, a Marker, Radiographic, Implantable (Class II — Special Controls, product code NEU), submitted by Augmenix, Inc. (Waltham, US). The FDA issued a Cleared decision on January 23, 2013, 202 days after receiving the submission on July 5, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K121964 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 05, 2012 |
| Decision Date | January 23, 2013 |
| Days to Decision | 202 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 |