Granudacyn® Wound Irrigation Solution
K-Number: K243415 · 2025-07-22
ApplicantP.G.F. Industry Solutions GmbH
Decision Date2025-07-22
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Granudacyn® Wound Irrigation Solution is a medical device manufactured by P.G.F. Industry Solutions GmbH. It received FDA 510(k) clearance on 2025-07-22 under approval number K243415. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Granudacyn® Wound Irrigation Solution?
Granudacyn® Wound Irrigation Solution is a medical device that received FDA 510(k) clearance on 2025-07-22. It is manufactured by P.G.F. Industry Solutions GmbH. The 510(k) number is K243415.
When was Granudacyn® Wound Irrigation Solution approved by the FDA?
Granudacyn® Wound Irrigation Solution received FDA 510(k) clearance on 2025-07-22, under approval number K243415.
What company makes Granudacyn® Wound Irrigation Solution?
Granudacyn® Wound Irrigation Solution is manufactured by P.G.F. Industry Solutions GmbH.
What is the FDA product code for Granudacyn® Wound Irrigation Solution?
The FDA product code for Granudacyn® Wound Irrigation Solution is FRO. This falls under the Anesthesiology category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.