Cleared Special

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)

K243936 · Staclear, Inc. · General Hospital

Apr 2025

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K243936 is an FDA 510(k) clearance for the StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL), a Ophthalmic Syringe (Class II — Special Controls, product code QLY), submitted by Staclear, Inc. (Raleigh, US). The FDA issued a Cleared decision on April 3, 2025, 104 days after receiving the submission on December 20, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K243936 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2024
Decision Date	April 03, 2025
Days to Decision	104 days
Submission Type	Special
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.