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FDA 510(k)

Derma-Gide

K-Number: K260532 · 2026-03-19

ApplicantGeistlich Pharma AG
Decision Date2026-03-19
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Derma-Gide is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich Pharma AG. It received FDA 510(k) clearance on 2026-03-19 under 510(k) number K260532. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Derma-Gide?

Derma-Gide is a medical device that received FDA 510(k) clearance on 2026-03-19. The listed applicant is Geistlich Pharma AG. The 510(k) number is K260532.

When did Derma-Gide receive FDA 510(k) clearance?

Derma-Gide received FDA 510(k) clearance on 2026-03-19, under 510(k) number K260532.

Who is the listed applicant for Derma-Gide?

The FDA 510(k) record lists Geistlich Pharma AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Derma-Gide?

The FDA product code for Derma-Gide is KGN.

Other records listing Geistlich Pharma AG as applicant

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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Related Devices (Code: KGN)

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.

K260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.

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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