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510(k) K143129

easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit) by Ezisurg Medical Co., Ltd. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2015
Date Received
October 31, 2014
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

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  • K172960 — easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM U (December 21, 2017)

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