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FDA 510(k)

Omeza Collagen Matrix

K-Number: K211972 · 2021-09-01

ApplicantOmeza, LLC
Decision Date2021-09-01
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Omeza Collagen Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Omeza, LLC. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K211972. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omeza Collagen Matrix?

Omeza Collagen Matrix is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is Omeza, LLC. The 510(k) number is K211972.

When did Omeza Collagen Matrix receive FDA 510(k) clearance?

Omeza Collagen Matrix received FDA 510(k) clearance on 2021-09-01, under 510(k) number K211972.

Who is the listed applicant for Omeza Collagen Matrix?

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

What is the FDA product code for Omeza Collagen Matrix?

The FDA product code for Omeza Collagen Matrix is FRO. This falls under the Anesthesiology category.

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.

NCT07161830Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot UlcersRECRUITINGNCT07754526OCM™ Treatment With Routine Care in Venous Leg Ulcers Compared to Routine Care Treatment Alone.NOT_YET_RECRUITING

Related Devices (Code: FRO)

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.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

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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