FDA 510(k)

Miromatrix Biological Mesh

K-Number: K160400 · 2016-06-08

Decision Date2016-06-08

Product CodeOXH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Miromatrix Biological Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Miromatrix Medical, Inc.. It received FDA 510(k) clearance on 2016-06-08 under 510(k) number K160400. The device is classified under product code OXH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Miromatrix Biological Mesh?

Miromatrix Biological Mesh is a medical device that received FDA 510(k) clearance on 2016-06-08. The listed applicant is Miromatrix Medical, Inc.. The 510(k) number is K160400.

When did Miromatrix Biological Mesh receive FDA 510(k) clearance?

Miromatrix Biological Mesh received FDA 510(k) clearance on 2016-06-08, under 510(k) number K160400.

Who is the listed applicant for Miromatrix Biological Mesh?

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

What is the FDA product code for Miromatrix Biological Mesh?

The FDA product code for Miromatrix Biological Mesh is OXH.

Other records listing Miromatrix Medical, 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.

K162570Miromatrix Biological Mesh TW

Related Devices (Code: OXH)

K251844Kerecis SurgiBind (50241)Kerecis Limited K202430Kerecis ReconstructKerecis Limited K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)

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.