TSK SELECT Needle

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 25 Oct 2026.

Device name

Tsk Hypodermic Needle

Model / reference

PRE-21025, TSN-030002

Primary DI / UDI-DI

04580708068602

Basic UDI-DI

4571225300011U9

510(k) Number

K250284 ↗

FDA product code

FMI

EMDN code

A0199 Needles - other

Device class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 880.5570

EU registration type

Standard device

EU market of registration

Netherlands

Advisory committee

General Hospital

FDA decision

SESE Substantially Equivalent

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See all devices from Tsk Laboratory, Japan →

• What gauge sizes are available for the TSK SELECT Needle, and why might a clinician choose a specific gauge?

  The TSK SELECT Needle is available in multiple gauge sizes, including the smallest 34G variant. Clinicians may choose a specific gauge based on the procedure’s requirements—thinner gauges like 34G are ideal for delicate injections or patients with sensitive skin, reducing discomfort and minimizing tissue damage, while larger gauges may be used for faster fluid administration or thicker substances.

• Is the TSK SELECT Needle reusable, or is it intended for single-use only? How should it be handled to maintain sterility?

  The TSK SELECT Needle is explicitly designed for single-use only, as stated in its description. To maintain sterility, it should be stored in its original packaging until use and handled using standard aseptic techniques—never reused or reprocessed, as this could compromise patient safety and violate regulatory compliance.

• How is the TSK SELECT Needle regulated, and what does its FDA 510(k) clearance (K250284) mean for buyers?

  The TSK SELECT Needle holds an FDA 510(k) clearance (K250284) under the Traditional review pathway, meaning it has been deemed *substantially equivalent* to a legally marketed predicate device. This clearance confirms it meets U.S. safety and performance standards for general hospital use, including injections and fluid administration, while also complying with the EU’s MDR requirements for global markets.

• What storage instructions should be followed for the TSK SELECT Needle to ensure it remains sterile and functional?

  The needle should be stored in its original, unopened packaging to preserve sterility, following standard aseptic practices for single-use devices. Avoid exposure to extreme temperatures, moisture, or contamination, as these factors could compromise its integrity before use. Always check the packaging for expiration dates or damage before use.