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FDA 510(k)

ACELL UBM LYOPHILIZED WOUND DRESSING

K-Number: K021637 · 2002-12-19

ApplicantAcell, Inc.
Decision Date2002-12-19
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

ACELL UBM LYOPHILIZED WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Acell, Inc.. It received FDA 510(k) clearance on 2002-12-19 under 510(k) number K021637. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACELL UBM LYOPHILIZED WOUND DRESSING?

ACELL UBM LYOPHILIZED WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2002-12-19. The listed applicant is Acell, Inc.. The 510(k) number is K021637.

When did ACELL UBM LYOPHILIZED WOUND DRESSING receive FDA 510(k) clearance?

ACELL UBM LYOPHILIZED WOUND DRESSING received FDA 510(k) clearance on 2002-12-19, under 510(k) number K021637.

Who is the listed applicant for ACELL UBM LYOPHILIZED WOUND DRESSING?

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

What is the FDA product code for ACELL UBM LYOPHILIZED WOUND DRESSING?

The FDA product code for ACELL UBM LYOPHILIZED WOUND DRESSING is KGN.

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Other records listing Acell, 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.

K241724Cytal® Wound Matrix; Cytal® Burn MatrixK241706MicroMatrix® UBM ParticulateK230980MicroMatrix® FlexK191734MatriStem UBM Pericardial PatchK192725Cytal Wound Matrix 3-LayerK182259Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal

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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

View on FDA Database →

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

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