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FDA 510(k)

SurgiAid® Collagen Wound Dressing

K-Number: K223126 · 2023-10-11

ApplicantMaxigen Biotech, Inc.
Decision Date2023-10-11
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

SurgiAid® Collagen Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Maxigen Biotech, Inc.. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K223126. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgiAid® Collagen Wound Dressing?

SurgiAid® Collagen Wound Dressing is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is Maxigen Biotech, Inc.. The 510(k) number is K223126.

When did SurgiAid® Collagen Wound Dressing receive FDA 510(k) clearance?

SurgiAid® Collagen Wound Dressing received FDA 510(k) clearance on 2023-10-11, under 510(k) number K223126.

Who is the listed applicant for SurgiAid® Collagen Wound Dressing?

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

What is the FDA product code for SurgiAid® Collagen Wound Dressing?

The FDA product code for SurgiAid® Collagen Wound Dressing 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.

NCT07409571Palatal Wound Healing After Free Gingival Graft SurgeryRECRUITING

Other records listing Maxigen Biotech, 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.

K242100SurgiAid Collagen Wound Dressing (HA)K230529HealiAid Dental Collagen Wound 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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