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 Mesh, Surgical, Absorbable, Staple Line Reinforcement
510(k) Number K252906
Device Name ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
Applicant
Ethicon Endo-Surgery, LLC
475 Calle C , Pr United States
Guaynabo,  PR  00696
Applicant Contact Roberta Cabral Franca
Correspondent
Ethicon Endo-Surgery, LLC
475 Calle C , Pr United States
Guaynabo,  PR  00696
Correspondent Contact Roberta Cabral Franca
Regulation Number878.3300
Classification Product Code
OXC  
Date Received09/12/2025
Decision Date 01/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
-
-