Product code QLY— General Hospital
StaClear Syringe (3 models)
- Classification name
- Ophthalmic Syringe
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Total cleared
- 7
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QLY
FDA has cleared devices under product code QLY between 2020 and 2025, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2024
- 2023
- 2020
Top applicants under product code QLY
Recent clearances under product code QLY
- K251849 — StaClear Syringe (3 models)
- K243322 — Altaviz Intravitreal Syringe
- K243027 — Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)
- K243936 — StaClear Syringe (3 models)
- K243149 — Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
- K230372 — VitreJect Syringe
- K200242 — StaClear Syringe
Data sourced from openFDA. This site is unofficial and independent of the FDA.