K180443 is an FDA 510(k) clearance for the Tumark Vision. This device is classified as a Marker, Radiographic, Implantable (Class II - Special Controls, product code NEU).
Submitted by Somatex Medical Technologies GmbH (Teltow, DE). The FDA issued a Cleared decision on March 22, 2018, 30 days after receiving the submission on February 20, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K180443 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2018 |
| Decision Date | March 22, 2018 |
| Days to Decision | 30 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 |