K243415
- 510(k) number
- K243415
- Device name
- Granudacyn® Wound Irrigation Solution
- Applicant
- P.G.F. Industry Solutions GmbH AT
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2025-07-22
- Date received
- 2024-11-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243415.pdf
Official FDA record: K243415
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.