Cleared Traditional

STERiJECT Low Dead Space, STERiJECT The Invisible Needle

K231734 · Tsk Laboratory International Japan KK · General Hospital
Mar 2024
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K231734 is an FDA 510(k) clearance for the STERiJECT Low Dead Space, STERiJECT The Invisible Needle, a Low Dead Space Needle, Single Lumen, Hypodermic (Class II — Special Controls, product code QNS), submitted by Tsk Laboratory International Japan KK (Tochigi-Shi, JP). The FDA issued a Cleared decision on March 8, 2024, 268 days after receiving the submission on June 14, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K231734 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2023
Decision Date March 08, 2024
Days to Decision 268 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code QNS — Low Dead Space Needle, Single Lumen, Hypodermic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570
Definition A Low Dead Space Single Lumen Hypodermic Needle Is A Device Designed To Reduce Medication Waste. The Device Consists Of A Metal Tube That Is Sharpened At One End And At The Other End Joined To Connector Designed To Mate With A Piston Syringe. It May Or May Not Have Needle Safety Features. The Device Can Be Used By Health Care Professions Or For Self-injection By The Patient.