ECMT-100 WMD— 510(k) K253521
Substantially EquivalentEcm Therapeutics, Inc.
FDA 510(k) clearance K253521 for ECMT-100 WMD, Substantially Equivalent on 2026-06-18. Applicant: Ecm Therapeutics, Inc.. Device class: Unclassified.
Summary
ECMT-100 WMD from Ecm Therapeutics is filed under KGN, wound dressings with animal-derived materials. The record doesn't expand the name or describe the product beyond the code name.
The device class is listed as U, with no regulation number, and the classification panel is listed as Unknown. The General and Plastic Surgery review panel handled it as a Traditional 510(k).
Ecm Therapeutics filed from Warrendale, Pennsylvania. Review took 217 calendar days (November 13, 2025 to June 18, 2026).
Clearance details
- Applicant
- Ecm Therapeutics, Inc.
- Product code
- Product code KGN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warrendale, PA, US
Recent devices under product code KGN
view allAdverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . 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.