ClearCap Distal Attachment

Endoscopic Irrigation/suction System

Finemedix Co., Ltd.

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

Pre-market Notification Details

Device IDK202616
510k NumberK202616
Device Name:ClearCap Distal Attachment
ClassificationEndoscopic Irrigation/suction System
Applicant Finemedix Co., Ltd. 60, Maeyeo-ro, Dong-gu Daegu,  KR 41065
ContactSeok-jun Ma
CorrespondentApril Lee
Withus Group Inc 106 Superior Irvine,  CA  92620
Product CodeOCX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-09
Decision Date2021-02-19

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