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FDA 510(k)

ENDOFORM DERMAL TEMPLATE

K-Number: K092096 · 2010-01-21

ApplicantMesynthes, Ltd.
Decision Date2010-01-21
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

ENDOFORM DERMAL TEMPLATE is the device name listed in this FDA 510(k) record. The listed applicant is Mesynthes, Ltd.. It received FDA 510(k) clearance on 2010-01-21 under 510(k) number K092096. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOFORM DERMAL TEMPLATE?

ENDOFORM DERMAL TEMPLATE is a medical device that received FDA 510(k) clearance on 2010-01-21. The listed applicant is Mesynthes, Ltd.. The 510(k) number is K092096.

When did ENDOFORM DERMAL TEMPLATE receive FDA 510(k) clearance?

ENDOFORM DERMAL TEMPLATE received FDA 510(k) clearance on 2010-01-21, under 510(k) number K092096.

Who is the listed applicant for ENDOFORM DERMAL TEMPLATE?

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

What is the FDA product code for ENDOFORM DERMAL TEMPLATE?

The FDA product code for ENDOFORM DERMAL TEMPLATE 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.

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Other records listing Mesynthes, Ltd. 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.

K101546ENDOFORM DENTAL TEMPLATE

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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