ClearTip TBNA Type
K-Number: K251478 · 2026-04-16
ApplicantFinemedix Co., Ltd.
Decision Date2026-04-16
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
ClearTip TBNA Type is a medical device manufactured by Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2026-04-16 under approval number K251478. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ClearTip TBNA Type?
ClearTip TBNA Type is a medical device that received FDA 510(k) clearance on 2026-04-16. It is manufactured by Finemedix Co., Ltd.. The 510(k) number is K251478.
When was ClearTip TBNA Type approved by the FDA?
ClearTip TBNA Type received FDA 510(k) clearance on 2026-04-16, under approval number K251478.
What company makes ClearTip TBNA Type?
ClearTip TBNA Type is manufactured by Finemedix Co., Ltd..
What is the FDA product code for ClearTip TBNA Type?
The FDA product code for ClearTip TBNA Type is KTI.
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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.