K253521
- 510(k) number
- K253521
- Device name
- ECMT-100 WMD
- Applicant
- Ecm Therapeutics, Inc. PA · US
- Product code
- KGN — Wound Dressing With Animal-Derived Material(S)
- Decision date
- 2026-06-18
- Date received
- 2025-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253521.pdf
Official FDA record: K253521
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.