QLY · Ophthalmic Syringe
General Hospital · 21 CFR 880.5860 · Class 2
Overview
| Product Code | QLY |
|---|---|
| Device Name | Ophthalmic Syringe |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251849 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. | Nov 21, 2025 | SESE |
| K243322 | Altaviz Intravitreal Syringe | Altaviz, LLC | May 9, 2025 | SESE |
| K243027 | Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) | Hangzhou Sightnovo Medical Technology Co., Ltd. | Apr 8, 2025 | SESE |
| K243936 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. | Apr 3, 2025 | SESE |
| K243149 | Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) | Congruence Medical Solutions, LLC | Dec 20, 2024 | SESE |
| K230372 | VitreJect Syringe | Ocuject, LLC | Sep 8, 2023 | SESE |
| K200242 | StaClear Syringe | Tribofilm Research, Inc. | Jul 27, 2020 | SESE |
Top Applicants
- Staclear, Inc. — 2 clearances
- Altaviz, LLC — 1 clearance
- Congruence Medical Solutions, LLC — 1 clearance
- Hangzhou Sightnovo Medical Technology Co., Ltd. — 1 clearance
- Ocuject, LLC — 1 clearance
