Miromatrix Biological Mesh TW— 510(k) K162570

Name: FDA 510(k) clearance K162570
Creator: U.S. Food and Drug Administration
Published: 2017-02-16

Substantially Equivalent

Miromatrix Medical, Inc.

FDA 510(k) clearance K162570 for Miromatrix Biological Mesh TW, Substantially Equivalent on 2017-02-16. Applicant: Miromatrix Medical, Inc.. Device class: 2.

Clearance details

Applicant: Miromatrix Medical, Inc.
Product code: Code FTM
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2016-09-15
Decision date: 2017-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Miromatrix Medical, Inc.

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K160400 — Miromatrix Biological Mesh2016-06-08
K150341 — Miromatrix Biological Mesh RS2015-05-12
K143426 — Wound Matrix TF2015-01-27
K140510 — MIROMATRIX WOUND MATRIX2014-06-19
K134033 — MIROMATRIX BIOLOGICAL MESH2014-03-31

Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.