K191797 is an FDA 510(k) clearance for the BiomarC Fiducial Marker. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Carbon Medical Technologies (St. Paul, US). The FDA issued a Cleared decision on July 29, 2019, 26 days after receiving the submission on July 3, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K191797 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2019 |
| Decision Date | July 29, 2019 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | IYE - Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |