• 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 K163454
Device Name ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm
Applicant
ETHICON ENDO-SURGERY, LLC
475 CALLE C
Guaynabo,  PR  00969
Applicant Contact Carmen Ortiz
Correspondent
ETHICON ENDO SURGERY, INC.
4545 CREEK ROAD
CINCINNATI,  OH  45242
Correspondent Contact Asifa Vonhof
Regulation Number878.4750
Classification Product Code
GDW  
Date Received12/09/2016
Decision Date 01/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-