510(k) K253923 ยท PHN Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
PuraStat
| Applicant | 3-D Matrix Europe SAS, Caluire Et Cuire, FR |
| Decision | Substantially Equivalent, Jan 7, 2026 |
| Received | Dec 8, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253923
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.