FDA 510(k)

Granudacyn® Wound Irrigation Solution

K-Number: K243415 · 2025-07-22

Decision Date2025-07-22

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.