K200167 is an FDA 510(k) clearance for the QuikClot Control+. 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 April 23, 2020, 91 days after receiving the submission on January 23, 2020.
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 | K200167 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2020 |
| Decision Date | April 23, 2020 |
| Days to Decision | 91 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 |