Clear-Tip EUS-FNA
K-Number: K180363 · 2018-11-01
ApplicantFinemedix Co., Ltd.
Decision Date2018-11-01
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Clear-Tip EUS-FNA is a medical device manufactured by Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2018-11-01 under approval number K180363. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Clear-Tip EUS-FNA?
Clear-Tip EUS-FNA is a medical device that received FDA 510(k) clearance on 2018-11-01. It is manufactured by Finemedix Co., Ltd.. The 510(k) number is K180363.
When was Clear-Tip EUS-FNA approved by the FDA?
Clear-Tip EUS-FNA received FDA 510(k) clearance on 2018-11-01, under approval number K180363.
What company makes Clear-Tip EUS-FNA?
Clear-Tip EUS-FNA is manufactured by Finemedix Co., Ltd..
What is the FDA product code for Clear-Tip EUS-FNA?
The FDA product code for Clear-Tip EUS-FNA is FCG.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.