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 K070887
Device Name ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)
Applicant
ETHICON ENDO-SURGERY, LLC
4545 CREEK ROAD
CINCINNATI,  OH  45242
Applicant Contact DENNIS HAHN
Correspondent
ETHICON ENDO-SURGERY, LLC
4545 CREEK ROAD
CINCINNATI,  OH  45242
Correspondent Contact DENNIS HAHN
Regulation Number878.4750
Classification Product Code
GDW  
Date Received03/30/2007
Decision Date 05/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-