K222025
- 510(k) number
- K222025
- Device name
- G4Derm / G4Derm Plus Synthetic Wound Matrix
- Applicant
- Gel4med, Inc. MA · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2023-10-11
- Date received
- 2022-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K222025.pdf
Official FDA record: K222025
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.