Cleared Traditional

Hypodermic Needle-Pro? EDGE? Safety Device with Low Dead Space Syringe

K232943 · Smiths Medical Asd, Inc. · General Hospital
May 2024
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K232943 is an FDA 510(k) clearance for the Hypodermic Needle-Pro? EDGE? Safety Device with Low Dead Space Syringe, a Low Dead Space Piston Syringe (Class II — Special Controls, product code QNQ), submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 31, 2024, 254 days after receiving the submission on September 20, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K232943 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2023
Decision Date May 31, 2024
Days to Decision 254 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code QNQ — Low Dead Space Piston Syringe
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860
Definition A Low Dead Space Syringe Is A Piston Syringe Designed To Reduce Medication Waste. The Device Consists Of A Calibrated Hollow Barrel, A Moveable Plunger, And May Include A Needle. The Device Can Be Used By Health Care Professions Or For Self-injection By The Patient.

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