Cleared Special

Miromatrix Biological Mesh

K160400 · Miromatrix Medical, Inc. · General & Plastic Surgery
Jun 2016
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K160400 is an FDA 510(k) clearance for the Miromatrix Biological Mesh, a Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery (Class II — Special Controls, product code OXH), submitted by Miromatrix Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on June 8, 2016, 117 days after receiving the submission on February 12, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K160400 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2016
Decision Date June 08, 2016
Days to Decision 117 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code OXH — Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.