K220971 is an FDA 510(k) clearance for the QuikClot Control+ Hemostatic Dressing. This device is classified as a Temporary, Internal Use Hemostatic (Class II - Special Controls, product code POD).
Submitted by Z-Medica, LLC (Wallingford, US). The FDA issued a Cleared decision on December 14, 2022, 254 days after receiving the submission on April 4, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4454. Intended To Control Severely Bleeding Wounds.
| 510(k) Number | K220971 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2022 |
| Decision Date | December 14, 2022 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | POD — Temporary, Internal Use Hemostatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4454 |
| Definition | Intended To Control Severely Bleeding Wounds |