510(k) K210098 ยท QAU Hemostatic Device For Endoscopic Gastrointestinal Use
PuraStat-GI
| Applicant | 3-D Matrix, Inc., Newton MA, US |
| Decision | Substantially Equivalent, Jun 25, 2021 |
| Received | Jan 14, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210098
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.