Granudacyn® Wound Irrigation Solution— 510(k) K243415

Name: FDA 510(k) clearance K243415
Creator: U.S. Food and Drug Administration
Published: 2025-07-22

Substantially Equivalent

P.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. Device class: Unclassified.

Clearance details

Applicant: P.G.F. Industry Solutions GmbH
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2024-11-01
Decision date: 2025-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elixhausen, AT

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRO

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K254041 — SkinSmart Antimicrobial HydroGel2026-09-11
K261646 — Redermax® Antibacterial Wound Matrix2026-08-14
K253665 — Vashe Plus Antimicrobial Solution2026-08-11
K251929 — SilverCeuticals® Antimicrobial Wound Gel2026-06-24
K261023 — Microdacyn Wound Irrigation Solution2026-06-24

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.