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FDA 510(k)

Cytal® Wound Matrix; Cytal® Burn Matrix

K-Number: K241724 · 2024-07-11

ApplicantAcell, Inc.
Decision Date2024-07-11
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Cytal® Wound Matrix; Cytal® Burn Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Acell, Inc.. It received FDA 510(k) clearance on 2024-07-11 under 510(k) number K241724. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cytal® Wound Matrix; Cytal® Burn Matrix?

Cytal® Wound Matrix; Cytal® Burn Matrix is a medical device that received FDA 510(k) clearance on 2024-07-11. The listed applicant is Acell, Inc.. The 510(k) number is K241724.

When did Cytal® Wound Matrix; Cytal® Burn Matrix receive FDA 510(k) clearance?

Cytal® Wound Matrix; Cytal® Burn Matrix received FDA 510(k) clearance on 2024-07-11, under 510(k) number K241724.

Who is the listed applicant for Cytal® Wound Matrix; Cytal® Burn Matrix?

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; Cytal® Burn Matrix?

The FDA product code for Cytal® Wound Matrix; Cytal® Burn Matrix 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®RECRUITING

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.

K241706MicroMatrix® UBM ParticulateK230980MicroMatrix® FlexK191734MatriStem UBM Pericardial PatchK192725Cytal Wound Matrix 3-LayerK182259Gentrix 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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