Wound Matrix TF
FDA 510(k) K143426 · Miromatrix Medical, Inc.
510(k) numberK143426
Submission
- Device name
- Wound Matrix TF
- Applicant
- Miromatrix Medical, Inc.
Eden Prairie, MN, US - Received
- December 1, 2014
- Decision date
- January 27, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KGN – Wound Dressing With Animal-Derived Material(S)
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code KGN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260652 | ColActive PlusKGN · Traditional | Covalon Technologies, Ltd. | 09/09/2026SE |
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…KGN · Traditional | Berkeley Advanced Biomaterials | 08/27/2026SE |
| K260596 | Collagen Wound PowderKGN · Traditional | Ventris Medical | 07/02/2026SE |
| K260669 | Endoform Dermal TemplateKGN · Traditional | Aroa Biosurgery , Ltd. | 06/24/2026SE |
| K253521 | ECMT-100 WMDKGN · Traditional | Ecm Therapeutics, Inc. | 06/18/2026SE |
| K253204 | CatalyzeKGN · Traditional | BioTissue Holdings, Inc. | 06/05/2026SE |
| K254034 | Roosin Collagen PowderKGN · Traditional | Roosin Medical Co., Ltd. | 06/03/2026SE |
| K253974 | Roosin Collagen DressingKGN · Traditional | Roosin Medical Co., Ltd. | 06/03/2026SE |
| K261224 | MatriDermKGN · Special | Medskin Solutions Dr. Suwelack AG | 05/14/2026SE |
| K260532 | Derma-GideKGN · Special | Geistlich Pharma AG | 03/19/2026SE |
More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K162570 | Miromatrix Biological Mesh TWFTM · Traditional | 02/16/2017SE |
| K160400 | Miromatrix Biological MeshOXH · Special | 06/08/2016SE |
| K150341 | Miromatrix Biological Mesh RSOXH · Traditional | 05/12/2015SE |
| K140510 | Miromatrix Wound MatrixKGN · Traditional | 06/19/2014SE |
| K134033 | Miromatrix Biological MeshFTM · Traditional | 03/31/2014SE |
Questions and answers
When was Wound Matrix TF cleared by the FDA?
Wound Matrix TF (K143426) received a 510(k) decision of Substantially Equivalent on January 27, 2015, 57 days after the submission was received.
What is the product code of K143426?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.