Panels › General Hospital › Product code QLY · Class 2
Ophthalmic Syringe
Regulation 880.5860
1510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QLY
| Company | 510(k)s | Recalls |
|---|---|---|
| Staclear, Inc. | 2 | 0 |
| Altaviz, LLC | 1 | 0 |
| Congruence Medical Solutions, LLC | 1 | 0 |
| Hangzhou Sightnovo Medical Technology Co., Ltd. | 1 | 0 |
| Ocuject, LLC | 1 | 0 |
| Tribofilm Research, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 2025 | K251849 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) Staclear, Inc. | QLY |
| May 9, 2025 | K243322 | Altaviz Intravitreal Syringe Altaviz, LLC | QLY |
| Apr 8, 2025 | 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., CN | QLY |
| Apr 3, 2025 | K243936 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) Staclear, Inc. | QLY |
| Dec 20, 2024 | K243149 | Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) Congruence Medical Solutions, LLC | QLY |
| Sep 8, 2023 | K230372 | VitreJect Syringe Ocuject, LLC | QLY |
| Jul 27, 2020 | K200242 | StaClear Syringe Tribofilm Research, Inc. | QLY |
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