ClearGrasp Snare

Snare, Flexible

Finemedix Co., Ltd.

The following data is part of a premarket notification filed by Finemedix Co., Ltd. with the FDA for Cleargrasp Snare.

Pre-market Notification Details

Device IDK183289
510k NumberK183289
Device Name:ClearGrasp Snare
ClassificationSnare, Flexible
Applicant Finemedix Co., Ltd. 60, Maeyeo-ro, Dong-gu Daegu,  KR 41065
ContactHee Kyung Kwon
CorrespondentApril Lee
Withus Group Inc 106 Superior Irvine,  CA  92620
Product CodeFDI  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-26
Decision Date2019-03-06

NIH GUDID Devices

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