Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K253521
Device Name ECMT-100 WMD
Applicant
Ecm Therapeutics, Inc.
118 Marshall Dr.
Warrendale,  PA  15086
Applicant Contact Russell Kronengold
Correspondent
Ecm Therapeutics, Inc.
118 Marshall Dr.
Warrendale,  PA  15086
Correspondent Contact Cynthia Berringer
Classification Product Code
KGN  
Date Received11/13/2025
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-