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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