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FDA 510(k)

MEDIFIL

K-Number: K910944 · 1991-04-02

ApplicantBiocore
Decision Date1991-04-02
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

MEDIFIL is the device name listed in this FDA 510(k) record. The listed applicant is Biocore. It received FDA 510(k) clearance on 1991-04-02 under 510(k) number K910944. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIFIL?

MEDIFIL is a medical device that received FDA 510(k) clearance on 1991-04-02. The listed applicant is Biocore. The 510(k) number is K910944.

When did MEDIFIL receive FDA 510(k) clearance?

MEDIFIL received FDA 510(k) clearance on 1991-04-02, under 510(k) number K910944.

Who is the listed applicant for MEDIFIL?

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

What is the FDA product code for MEDIFIL?

The FDA product code for MEDIFIL 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 Biocore 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.

K925545SKINTEMP, MODIFICATIONK913023SKINTEMP

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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