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 K191070
Device Name Signia Small Diameter Reloads
Applicant
Covidien
60 Middletown Avenue
North Haven,  CT  06473
Applicant Contact Frank Gianelli
Correspondent
Covidien
60 Middletown Avenue
North Haven,  CT  06473
Correspondent Contact Frank Gianelli
Regulation Number878.4750
Classification Product Code
GDW  
Date Received04/22/2019
Decision Date 09/04/2019
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
Recalls CDRH Recalls
-
-