K212158 is an FDA 510(k) clearance for the HydroMARK Breast Biopsy Site Marker. This device is classified as a Marker, Radiographic, Implantable (Class II - Special Controls, product code NEU).
Submitted by Devicor Medical Products, Inc. (Cincinnati, US). The FDA issued a Cleared decision on April 21, 2022, 283 days after receiving the submission on July 12, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K212158 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2021 |
| Decision Date | April 21, 2022 |
| Days to Decision | 283 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 |