DeviceClearance

ECMT-100 WMD— 510(k) K253521

Substantially Equivalent

Ecm Therapeutics, Inc.

FDA 510(k) clearance K253521 for ECMT-100 WMD, Substantially Equivalent on 2026-06-18. Applicant: Ecm Therapeutics, Inc..

Clearance details

Applicant
Ecm Therapeutics, Inc.
Product code
Code KGN
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warrendale, PA, US
Download summary PDFView on FDA.gov ↗

Adverse 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.