Cleared Traditional

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)

K243149 · Congruence Medical Solutions, LLC · General Hospital

Dec 2024

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K243149 is an FDA 510(k) clearance for the Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models), a Ophthalmic Syringe (Class II — Special Controls, product code QLY), submitted by Congruence Medical Solutions, LLC (Baltimore, US). The FDA issued a Cleared decision on December 20, 2024, 81 days after receiving the submission on September 30, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K243149 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	December 20, 2024
Days to Decision	81 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	QLY — Ophthalmic Syringe
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5860
Definition	An Ophthalmic Syringe Is A Piston Syringe Intended For Intraocular Injections. The Device Consists Of A Calibrated Hollow Barrel, A Movable Plunger, And May Include A Needle. The Device Should Be Used By Health Care Professionals To Perform Injections Into The Eye.