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FDA 510(k)

Cytal Wound Particulate

K-Number: K180776 · 2018-05-11

ApplicantAcell, Inc.
Decision Date2018-05-11
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Cytal Wound Particulate is the device name listed in this FDA 510(k) record. The listed applicant is Acell, Inc.. It received FDA 510(k) clearance on 2018-05-11 under 510(k) number K180776. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cytal Wound Particulate?

Cytal Wound Particulate is a medical device that received FDA 510(k) clearance on 2018-05-11. The listed applicant is Acell, Inc.. The 510(k) number is K180776.

When did Cytal Wound Particulate receive FDA 510(k) clearance?

Cytal Wound Particulate received FDA 510(k) clearance on 2018-05-11, under 510(k) number K180776.

Who is the listed applicant for Cytal Wound Particulate?

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 Particulate?

The FDA product code for Cytal Wound Particulate is KGN.

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

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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