510(k) K202467

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads by Fengh Medical Co., Ltd. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2020
Date Received
August 27, 2020
Clearance Type
Special
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