FDA 510(k)

Granudacyn® Wound Irrigation Solution

Número K: K243415 · 2025-07-22

RequerenteP.G.F. Industry Solutions GmbH

Data da decisão2025-07-22

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Granudacyn® Wound Irrigation Solution is the device name listed in this FDA 510(k) record. The listed applicant is P.G.F. Industry Solutions GmbH. It received FDA 510(k) clearance on 2025-07-22 under 510(k) 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.

Perguntas frequentes

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. The listed applicant is P.G.F. Industry Solutions GmbH. The 510(k) number is K243415.

When did Granudacyn® Wound Irrigation Solution receive FDA 510(k) clearance?

Granudacyn® Wound Irrigation Solution received FDA 510(k) clearance on 2025-07-22, under 510(k) number K243415.

Who is the listed applicant for Granudacyn® Wound Irrigation Solution?

The FDA 510(k) record lists P.G.F. Industry Solutions GmbH as the applicant. This does not by itself establish the device manufacturer.

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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Fonte oficial

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