510(k) K222909 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Axiostat Gauze
| Applicant | Advamedica, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Apr 7, 2023 |
| Received | Sep 26, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222909
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.