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 Staple, Implantable
510(k) Number K141952
Device Name ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
Applicant
ETHICON ENDO-SURGERY, INC.
4545 CREEK ROAD
CINCINNATI,  OH  45242
Applicant Contact LINDA HILL
Correspondent
ETHICON ENDO-SURGERY, INC.
4545 CREEK ROAD
CINCINNATI,  OH  45242
Correspondent Contact LINDA HILL
Regulation Number878.4750
Classification Product Code
GDW  
Date Received07/18/2014
Decision Date 11/24/2014
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		 No
Recalls CDRH Recalls
-
-