Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Geistlich Derma-Gide

K-Number: K182838 · 2018-11-08

ApplicantGeistlich Pharma AG
Decision Date2018-11-08
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Geistlich 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 2018-11-08 under 510(k) number K182838. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Geistlich Derma-Gide?

Geistlich Derma-Gide is a medical device that received FDA 510(k) clearance on 2018-11-08. The listed applicant is Geistlich Pharma AG. The 510(k) number is K182838.

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

Geistlich Derma-Gide received FDA 510(k) clearance on 2018-11-08, under 510(k) number K182838.

Who is the listed applicant for Geistlich 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 Geistlich Derma-Gide?

The FDA product code for Geistlich 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.

K260364Device 300419 StripK260532Derma-GideK251323Device 104 ParticulateK252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi PackK251556Device 300423 Granules

View all 22 devices →

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.

↑