Class Class II
TSK SELECT™ Needle (K250284)
Description
TSK SELECT™ Needle by Tsk Laboratory, Japan, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250284
Clearance Date2025-07-24
Clearance TypeTraditional
Product CodeFMI
Regulation Number880.5570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250284
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. TSK SELECT™ Needle (K250284) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210444 | EZ-Injec LDV Sterile Safety Needle | Poonglim Pharmatech, Inc. | 2021 |
Trace the full predicate network for K250284
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.