EasyEndo Lite Linear Cutting Stapler And Loading Unit For Single Use

Staple, Implantable

Ezisurg Medical Co., Ltd.

The following data is part of a premarket notification filed by Ezisurg Medical Co., Ltd. with the FDA for Easyendo Lite Linear Cutting Stapler And Loading Unit For Single Use.

Pre-market Notification Details

Device IDK210909
510k NumberK210909
Device Name:EasyEndo Lite Linear Cutting Stapler And Loading Unit For Single Use
ClassificationStaple, Implantable
Applicant Ezisurg Medical Co., Ltd. Rm. 103, Bldg. 2, No.1690 Cailun Rd., China (Shanghai) Pilot Shanghai,  CN 201203
ContactJingtian Ren
CorrespondentDiana Hong
Mid-Linking Consulting Co., Ltd. P.O. Box 120-119 Shanghai,  CN 200120
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-29
Decision Date2021-06-24

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