510(k) K250397 ยท KGN Wound Dressing With Animal-Derived Material(S)
Helios Dermal Scaffold
| Applicant | Helios Biomedical, Inc., Weston MA, US |
| Decision | Substantially Equivalent, Aug 15, 2025 |
| Received | Feb 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250397
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.