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FDA 510(k)

Cytal Wound Matrix 3-Layer

K-Number: K192725 · 2019-10-25

ApplicantAcell, Inc.
Decision Date2019-10-25
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Cytal Wound Matrix 3-Layer is the device name listed in this FDA 510(k) record. The listed applicant is Acell, Inc.. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K192725. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cytal Wound Matrix 3-Layer?

Cytal Wound Matrix 3-Layer is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Acell, Inc.. The 510(k) number is K192725.

When did Cytal Wound Matrix 3-Layer receive FDA 510(k) clearance?

Cytal Wound Matrix 3-Layer received FDA 510(k) clearance on 2019-10-25, under 510(k) number K192725.

Who is the listed applicant for Cytal Wound Matrix 3-Layer?

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 Cytal Wound Matrix 3-Layer?

The FDA product code for Cytal Wound Matrix 3-Layer 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.

NCT06857708The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix®RECRUITINGNCT07701590CAMPR-II RWE TRIAL: A Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Hard to Heal DFUs and VLUsRECRUITING

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 PatchK182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalK180776Cytal Wound Particulate

View all 11 devices →

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.

K260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.

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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