Granudacyn® Wound Irrigation Solution— 510(k) K243415
Substantially EquivalentP.G.F. Industry Solutions GmbH
FDA 510(k) clearance K243415 for Granudacyn® Wound Irrigation Solution, Substantially Equivalent on 2025-07-22. Applicant: P.G.F. Industry Solutions GmbH.
Clearance details
- Applicant
- P.G.F. Industry Solutions GmbH
- Product code
- Code FRO
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elixhausen, AT
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.