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510(k) K211811

Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers by Wuxi Beien Surgery Device Co., Ltd. — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2022
Date Received
June 11, 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

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