Cleared Traditional

StaClear Syringe

K200242 · Tribofilm Research, Inc. · General Hospital

Jul 2020

Decision

178d

Days

Class 2

Risk

About This 510(k) Submission

K200242 is an FDA 510(k) clearance for the StaClear Syringe, a Ophthalmic Syringe (Class II — Special Controls, product code QLY), submitted by Tribofilm Research, Inc. (Raleigh, US). The FDA issued a Cleared decision on July 27, 2020, 178 days after receiving the submission on January 31, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K200242 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2020
Decision Date	July 27, 2020
Days to Decision	178 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.