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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Tsk Laboratory, Japan. It received FDA 510(k) clearance on 2025-07-24 under 510(k) 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. The listed applicant is Tsk Laboratory, Japan. The 510(k) number is K250284.

When did TSK SELECT™ Needle receive FDA 510(k) clearance?

TSK SELECT™ Needle received FDA 510(k) clearance on 2025-07-24, under 510(k) number K250284.

Who is the listed applicant for TSK SELECT™ Needle?

The FDA 510(k) record lists Tsk Laboratory, Japan as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TSK SELECT™ Needle?

The FDA product code for TSK SELECT™ Needle is FMI.

Other records listing Tsk Laboratory, Japan as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250127TSK Syringe

Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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