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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 a medical device manufactured by Acell, Inc.. It received FDA 510(k) clearance on 2018-05-11 under approval 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. It is manufactured by Acell, Inc.. The 510(k) number is K180776.

When was Cytal Wound Particulate approved by the FDA?

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

What company makes Cytal Wound Particulate?

Cytal Wound Particulate is manufactured by Acell, Inc..

What is the FDA product code for Cytal Wound Particulate?

The FDA product code for Cytal Wound Particulate is KGN.

Related Clinical Trials

NCT07414368 Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate for Acute and Chronic Wounds ENROLLING_BY_INVITATION NCT06857708 The Management of Necrotizing Soft Tissue Infection Wounds With Cytal® Wound Matrix and MicroMatrix® RECRUITING

Other Devices by Acell, Inc.

K162554Gentrix Surgical Matrix K153754MicroMatrix K172399MicroMatrix K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend K191734MatriStem UBM Pericardial Patch K192725Cytal Wound Matrix 3-Layer

View all 11 devices →

Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma AG

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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