K250329
- 510(k) number
- K250329
- Device name
- GeniPhys Collymer Self-Assembling Scaffold
- Applicant
- Geniphys, Inc. IN · US
- Product code
- KGN — Wound Dressing With Animal-Derived Material(S)
- Decision date
- 2025-06-25
- Date received
- 2025-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250329.pdf
Official FDA record: K250329
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.