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FDA 510(k)

Miro3D Wound Matrix

K-Number: K223257 · 2022-11-21

Decision Date2022-11-21
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Miro3D Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Reprise Biomedical. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K223257. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Miro3D Wound Matrix?

Miro3D Wound Matrix is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Reprise Biomedical. The 510(k) number is K223257.

When did Miro3D Wound Matrix receive FDA 510(k) clearance?

Miro3D Wound Matrix received FDA 510(k) clearance on 2022-11-21, under 510(k) number K223257.

Who is the listed applicant for Miro3D Wound Matrix?

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

What is the FDA product code for Miro3D Wound Matrix?

The FDA product code for Miro3D Wound Matrix 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.

Other records listing Reprise Biomedical 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.

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.

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.