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FDA Product Code

FDA Product Code QLY — Clearance Directory

Device Class
Class II
Assigned Panel
General Hospital
21 CFR Citation
880.5860

510(k) Clearances — 7 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K251849 StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) Staclear, Inc. 2025-11-21 Traditional PDF ↗
K243322 Altaviz Intravitreal Syringe Altaviz, LLC 2025-05-09 Traditional PDF ↗
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. 2025-04-08 Traditional PDF ↗
K243936 StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) Staclear, Inc. 2025-04-03 Special PDF ↗
K243149 Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) Congruence Medical Solutions, LLC 2024-12-20 Traditional PDF ↗
K230372 VitreJect Syringe Ocuject, LLC 2023-09-08 Traditional PDF ↗
K200242 StaClear Syringe Tribofilm Research, Inc. 2020-07-27 Traditional PDF ↗

Product code QLY · Class II · General Hospital. Data: openFDA.