• 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 clip, implantable
510(k) Number K143598
Device Name Lapro-Clip Auto Suture Reusable Long Clip Applier
Applicant
Covidien LLC
60 Middletown Ave
North Haven,  CT  06473
Applicant Contact Rebecca Magnanimo
Correspondent
Covidien LLC
60 Middletown Ave
North Haven,  CT  06473
Correspondent Contact Rebecca Magnanimo
Regulation Number878.4300
Classification Product Code
FZP  
Date Received12/18/2014
Decision Date 03/12/2015
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
-
-