510(k) K222641

Signia™ Small Diameter Reloads Including Regular (Round) Tip Version by Covidien — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2022
Date Received
September 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type