FDA 510(k)

G4Derm / G4Derm Plus Synthetic Wound Matrix

Número K: K222025 · 2023-10-11

Data da decisão2023-10-11

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

G4Derm / G4Derm Plus Synthetic Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Gel4med, Inc.. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K222025. 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 G4Derm / G4Derm Plus Synthetic Wound Matrix?

G4Derm / G4Derm Plus Synthetic Wound Matrix is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is Gel4med, Inc.. The 510(k) number is K222025.

When did G4Derm / G4Derm Plus Synthetic Wound Matrix receive FDA 510(k) clearance?

G4Derm / G4Derm Plus Synthetic Wound Matrix received FDA 510(k) clearance on 2023-10-11, under 510(k) number K222025.

Who is the listed applicant for G4Derm / G4Derm Plus Synthetic Wound Matrix?

The FDA 510(k) record lists Gel4med, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G4Derm / G4Derm Plus Synthetic Wound Matrix?

The FDA product code for G4Derm / G4Derm Plus Synthetic Wound Matrix is FRO. This falls under the Anesthesiology category.

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