Cleared Traditional

TopFine? LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))

K231856 · Medexel Co.,Ltd · General Hospital

Mar 2024

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K231856 is an FDA 510(k) clearance for the TopFine? LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)), a Low Dead Space Piston Syringe (Class II — Special Controls, product code QNQ), submitted by Medexel Co.,Ltd (Anseong, KR). The FDA issued a Cleared decision on March 15, 2024, 266 days after receiving the submission on June 23, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K231856 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2023
Decision Date	March 15, 2024
Days to Decision	266 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.