STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)— 510(k) K242073

Name: FDA 510(k) clearance K242073
Creator: U.S. Food and Drug Administration
Published: 2024-10-23

Substantially Equivalent

Tsk Laboratory International Japan KK

FDA 510(k) clearance K242073 for STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS), Substantially Equivalent on 2024-10-23. Applicant: Tsk Laboratory International Japan KK. Device class: 2.

Clearance details

Applicant: Tsk Laboratory International Japan KK
Product code: Code QYM
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 2024-07-16
Decision date: 2024-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tochigi-Shi, JP

Download summary PDF View on FDA.gov ↗

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