FDA 510(k) Applications for Medical Device Product Code "QLY"
| FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
| K243322 |
Altaviz, LLC |
Altaviz Intravitreal Syringe |
05/09/2025 |
| K243149 |
Congruence Medical Solutions, LLC |
Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) |
12/20/2024 |
| K243027 |
Hangzhou Sightnovo Medical Technology Co., Ltd. |
Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) |
04/08/2025 |
| K230372 |
OcuJect, LLC |
VitreJect Syringe |
09/08/2023 |
| K243936 |
StaClear, INC. |
StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) |
04/03/2025 |
| K200242 |
TriboFilm Research, Inc. |
StaClear Syringe |
07/27/2020 |
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