K213198 is an FDA 510(k) clearance for the Ax-Surgi Surgical Hemostat. This device is classified as a Temporary, Internal Use Hemostatic (Class II - Special Controls, product code POD).
Submitted by Advamedica, Inc. (Cambridge, US). The FDA issued a Cleared decision on January 5, 2023, 463 days after receiving the submission on September 29, 2021.
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 | K213198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2021 |
| Decision Date | January 05, 2023 |
| Days to Decision | 463 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 |