• 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 K171589
Device Name AEON Endoscopic Stapler
Applicant
Lexington Medical Inc.
11 Executive Park Dr.
billerica,  MA  01862
Applicant Contact donna gasper
Correspondent
Lexington Medical Inc.
11 Executive Park Dr.
billerica,  MA  01862
Correspondent Contact donna gasper
Regulation Number878.4750
Classification Product Code
GDW  
Date Received05/31/2017
Decision Date 11/17/2017
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
-
-