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FDA 510(k)

Maxiocel Chitosan Wound Dressing

K-Number: K212766 · 2023-08-24

ApplicantAdvamedica, Inc.
Decision Date2023-08-24
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Maxiocel Chitosan Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Advamedica, Inc.. It received FDA 510(k) clearance on 2023-08-24 under 510(k) number K212766. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Maxiocel Chitosan Wound Dressing?

Maxiocel Chitosan Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Advamedica, Inc.. The 510(k) number is K212766.

When did Maxiocel Chitosan Wound Dressing receive FDA 510(k) clearance?

Maxiocel Chitosan Wound Dressing received FDA 510(k) clearance on 2023-08-24, under 510(k) number K212766.

Who is the listed applicant for Maxiocel Chitosan Wound Dressing?

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

What is the FDA product code for Maxiocel Chitosan Wound Dressing?

The FDA product code for Maxiocel Chitosan Wound Dressing is KGN.

Other records listing Advamedica, 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.

K222909Axiostat GauzeK213198Ax-Surgi Surgical HemostatK202830Axiostat PatchK172324Axiostat Chitosan Hemostatic Dressing

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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