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510(k) K231856

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) by Medexel Co.,Ltd — Product Code QNQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2024
Date Received
June 23, 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.

Other clearances by Medexel Co.,Ltd

  • K172095 — Autokeeper (July 24, 2018)
  • K152410 — Top Fine Pen Needle (February 2, 2016)

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)
  • K232943 — Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe (May 31, 2024)
  • K241190 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volum (May 29, 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)