Cleared Special

LDS Needle; OcuSafe? LDS Needle; SteriCap? LDS Safety Needle; VitreJect? LDS Safety Needle

K242956 · Ocuject, LLC · General Hospital
Oct 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K242956 is an FDA 510(k) clearance for the LDS Needle; OcuSafe? LDS Needle; SteriCap? LDS Safety Needle; VitreJect? LDS Safety Needle, a Low Dead Space Needle, Single Lumen, Hypodermic (Class II — Special Controls, product code QNS), submitted by Ocuject, LLC (Newport Beach, US). The FDA issued a Cleared decision on October 25, 2024, 30 days after receiving the submission on September 25, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K242956 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2024
Decision Date October 25, 2024
Days to Decision 30 days
Submission Type Special
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.