K201863 is an FDA 510(k) clearance for the Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape. This device is classified as a Marker, Radiographic, Implantable (Class II - Special Controls, product code NEU).
Submitted by Somatex Medical Technologies GmbH (Berlin, DE). The FDA issued a Cleared decision on February 18, 2021, 227 days after receiving the submission on July 6, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K201863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2020 |
| Decision Date | February 18, 2021 |
| Days to Decision | 227 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 |