510(k) K261504 ยท PHN Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
PuraStat-RM
| Applicant | 3-D Matrix, Inc., Newton MA, US |
| Decision | Substantially Equivalent, Aug 3, 2026 |
| Received | May 6, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261504
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.