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)

AONGEN COLLAGEN MATRIX

K-Number: K080868 · 2009-05-14

ApplicantAeon Astron Europe B.V.
Decision Date2009-05-14
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

AONGEN 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 2009-05-14 under 510(k) number K080868. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AONGEN COLLAGEN MATRIX?

AONGEN COLLAGEN MATRIX is a medical device that received FDA 510(k) clearance on 2009-05-14. The listed applicant is Aeon Astron Europe B.V.. The 510(k) number is K080868.

When did AONGEN COLLAGEN MATRIX receive FDA 510(k) clearance?

AONGEN COLLAGEN MATRIX received FDA 510(k) clearance on 2009-05-14, under 510(k) number K080868.

Who is the listed applicant for AONGEN 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 AONGEN COLLAGEN MATRIX?

The FDA product code for AONGEN COLLAGEN MATRIX is KGN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Aeon Astron Europe B.V. 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.

K173223ologen Collagen MatrixK112568AONGEN DENTAL COLLAGEN MATRIX

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.

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 BiomaterialsK260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.

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.

↑