510(k) K232943

Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe by Smiths Medical Asd, Inc. — Product Code QNQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 31, 2024
Date Received: September 20, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Low Dead Space Piston Syringe
Device Class: Class II
Regulation Number: 880.5860
Review Panel: HO
Submission Type

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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Other clearances for product code QNQ

K252814 — Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low (February 19, 2026)
K250127 — TSK Syringe (July 30, 2025)
K250138 — Small Volume 0.2mL Syringe (April 2, 2025)
K242291 — SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low (November 20, 2024)
K241190 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volum (May 29, 2024)
K231856 — TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) (March 15, 2024)
K221860 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volum (September 15, 2023)
K213010 — FEELject LDV (Low dead volume) syringe (May 31, 2023)
K213013 — Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe (September 19, 2022)
K220083 — LDV((Low Dead Volume )Syringe (May 25, 2022)