FDA 510(k)

ologen Collagen Matrix

K-Number: K173223 · 2018-03-02

Decision Date2018-03-02

Product CodeKGN

DecisionSubstantially Equivalent

Device Summary

ologen Collagen Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Aeon Astron Europe B.V.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K173223. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ologen Collagen Matrix?

ologen Collagen Matrix is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Aeon Astron Europe B.V.. The 510(k) number is K173223.

When did ologen Collagen Matrix receive FDA 510(k) clearance?

ologen Collagen Matrix received FDA 510(k) clearance on 2018-03-02, under 510(k) number K173223.

Who is the listed applicant for ologen Collagen Matrix?

The FDA 510(k) record lists Aeon Astron Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ologen Collagen Matrix?

The FDA product code for ologen Collagen Matrix is KGN.

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 Medical K260669Endoform 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.