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FDA 510(k)

G4Derm / G4Derm Plus Synthetic Wound Matrix

K-Number: K222025 · 2023-10-11

ApplicantGel4med, Inc.
Decision Date2023-10-11
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

G4Derm / G4Derm Plus Synthetic Wound Matrix is a medical device manufactured by Gel4med, Inc.. It received FDA 510(k) clearance on 2023-10-11 under approval 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.

Frequently Asked Questions

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. It is manufactured by Gel4med, Inc.. The 510(k) number is K222025.

When was G4Derm / G4Derm Plus Synthetic Wound Matrix approved by the FDA?

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

What company makes G4Derm / G4Derm Plus Synthetic Wound Matrix?

G4Derm / G4Derm Plus Synthetic Wound Matrix is manufactured by Gel4med, Inc..

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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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.

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