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FDA 510(k)

Comatryx OTC

K-Number: K232758 · 2023-12-01

ApplicantStrukmyer Medical, LLC
Decision Date2023-12-01
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Comatryx OTC is the device name listed in this FDA 510(k) record. The listed applicant is Strukmyer Medical, LLC. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K232758. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Comatryx OTC?

Comatryx OTC is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Strukmyer Medical, LLC. The 510(k) number is K232758.

When did Comatryx OTC receive FDA 510(k) clearance?

Comatryx OTC received FDA 510(k) clearance on 2023-12-01, under 510(k) number K232758.

Who is the listed applicant for Comatryx OTC?

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

What is the FDA product code for Comatryx OTC?

The FDA product code for Comatryx OTC is KGN.

Other records listing Strukmyer Medical, LLC 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.

K171645CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottleK161311USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles

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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