Clear-Tip EUS-FNA

Biopsy Needle

Finemedix Co. Ltd.

The following data is part of a premarket notification filed by Finemedix Co. Ltd. with the FDA for Clear-tip Eus-fna.

Pre-market Notification Details

Device IDK180363
510k NumberK180363
Device Name:Clear-Tip EUS-FNA
ClassificationBiopsy Needle
Applicant Finemedix Co. Ltd. 60, Maeyeo-ro, Dong-gu Daegu,  KR 41065
ContactHeon Sik Lee
CorrespondentApril Lee
Withus Group Inc 106 Superior Irvine,  CA  92620
Product CodeFCG  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-09
Decision Date2018-11-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18809327352972 K180363 000
18809327352965 K180363 000
18809327352958 K180363 000
18809327352941 K180363 000
18809327352934 K180363 000
18809327352927 K180363 000

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