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510(k) K242073

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) by Tsk Laboratory International Japan KK — Product Code QYM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2024
Date Received
July 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmic Needle
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

An Ophthalmic Needle is a needle intended for intraocular injections. The device should be used by health care professionals to perform injections into the eye.

Other clearances by Tsk Laboratory International Japan KK

  • K231734 — STERiJECT Low Dead Space, STERiJECT The Invisible Needle (March 8, 2024)

Other clearances for product code QYM

  • K230951 — Terumo Injection Filter Needle (NF-3013RBKE05M) (October 18, 2023)