K100994 is an FDA 510(k) clearance for the PRELOADED TISSUE MARKER DEVICE. This device is classified as a Marker, Radiographic, Implantable (Class II - Special Controls, product code NEU).
Submitted by Carbon Medical Technologies, Inc. (St, Paul, US). The FDA issued a Cleared decision on April 30, 2010, 21 days after receiving the submission on April 9, 2010.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K100994 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2010 |
| Decision Date | April 30, 2010 |
| Days to Decision | 21 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 |