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510(k) K210909

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2021
Date Received
March 29, 2021
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

Other clearances by Ezisurg Medical Co., Ltd.

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  • K172960 — easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM U (December 21, 2017)
  • K143129 — easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading (January 29, 2015)

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