ECMT-100 WMD
FDA 510(k) K253521 · Ecm Therapeutics, Inc.
510(k) numberK253521
Submission
- Device name
- ECMT-100 WMD
- Applicant
- Ecm Therapeutics, Inc.
Warrendale, PA, US - Received
- November 13, 2025
- Decision date
- June 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
| K260218 | LacertaMatrixKGN · Special | Lacerta Life Sciences | 02/19/2026SE |
Questions and answers
When was ECMT-100 WMD cleared by the FDA?
ECMT-100 WMD (K253521) received a 510(k) decision of Substantially Equivalent on June 18, 2026, 217 days after the submission was received.
What is the product code of K253521?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.