Miromatrix Biological Mesh TW
FDA 510(k) K162570 · Miromatrix Medical, Inc.
510(k) numberK162570
Submission
- Device name
- Miromatrix Biological Mesh TW
- Applicant
- Miromatrix Medical, Inc.
Eden Prairie, MN, US - Received
- September 15, 2016
- Decision date
- February 16, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K160400 | Miromatrix Biological MeshOXH · Special | 06/08/2016SE |
| K150341 | Miromatrix Biological Mesh RSOXH · Traditional | 05/12/2015SE |
| K143426 | Wound Matrix TFKGN · Special | 01/27/2015SE |
| K140510 | Miromatrix Wound MatrixKGN · Traditional | 06/19/2014SE |
| K134033 | Miromatrix Biological MeshFTM · Traditional | 03/31/2014SE |
Questions and answers
When was Miromatrix Biological Mesh TW cleared by the FDA?
Miromatrix Biological Mesh TW (K162570) received a 510(k) decision of Substantially Equivalent on February 16, 2017, 154 days after the submission was received.
What is the product code of K162570?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.