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FDA 510(k)

SENTREX BIOSPONGE MPD

K-Number: K123961 · 2013-04-05

ApplicantBionova Medical, Inc.
Decision Date2013-04-05
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

SENTREX BIOSPONGE MPD is the device name listed in this FDA 510(k) record. The listed applicant is Bionova Medical, Inc.. It received FDA 510(k) clearance on 2013-04-05 under 510(k) number K123961. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENTREX BIOSPONGE MPD?

SENTREX BIOSPONGE MPD is a medical device that received FDA 510(k) clearance on 2013-04-05. The listed applicant is Bionova Medical, Inc.. The 510(k) number is K123961.

When did SENTREX BIOSPONGE MPD receive FDA 510(k) clearance?

SENTREX BIOSPONGE MPD received FDA 510(k) clearance on 2013-04-05, under 510(k) number K123961.

Who is the listed applicant for SENTREX BIOSPONGE MPD?

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

What is the FDA product code for SENTREX BIOSPONGE MPD?

The FDA product code for SENTREX BIOSPONGE MPD is KGN.

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Other records listing Bionova Medical, Inc. 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.

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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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