Cleared Traditional

STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)

K242073 · Tsk Laboratory International Japan KK · General Hospital
Oct 2024
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K242073 is an FDA 510(k) clearance for the STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS), a Ophthalmic Needle (Class II — Special Controls, product code QYM), submitted by Tsk Laboratory International Japan KK (Tochigi-Shi, JP). The FDA issued a Cleared decision on October 23, 2024, 99 days after receiving the submission on July 16, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K242073 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2024
Decision Date October 23, 2024
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code QYM — Ophthalmic Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570
Definition 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.