TSK SELECT Needle
K-Number: K250284 · 2025-07-24
ApplicantTsk Laboratory, Japan
Decision Date2025-07-24
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
TSK SELECT Needle is a medical device manufactured by Tsk Laboratory, Japan. It received FDA 510(k) clearance on 2025-07-24 under approval number K250284. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TSK SELECT Needle?
TSK SELECT Needle is a medical device that received FDA 510(k) clearance on 2025-07-24. It is manufactured by Tsk Laboratory, Japan. The 510(k) number is K250284.
When was TSK SELECT Needle approved by the FDA?
TSK SELECT Needle received FDA 510(k) clearance on 2025-07-24, under approval number K250284.
What company makes TSK SELECT Needle?
TSK SELECT Needle is manufactured by Tsk Laboratory, Japan.
What is the FDA product code for TSK SELECT Needle?
The FDA product code for TSK SELECT Needle is FMI.
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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.