FDA 510(k)

ologen Collagen Matrix

Numéro K : K173223 · 2018-03-02

Date de décision2018-03-02

Code produitKGN

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : KGN)

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)Berkeley Advanced Biomaterials K260596Collagen Wound PowderVentris Medical K260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.

Source officielle

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