FDA 510(k)

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)

Número K: K243149 · 2024-12-20

RequerenteCongruence Medical Solutions, LLC

Data da decisão2024-12-20

Código do produtoQLY

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) is the device name listed in this FDA 510(k) record. The listed applicant is Congruence Medical Solutions, LLC. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K243149. The device is classified under product code QLY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)?

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Congruence Medical Solutions, LLC. The 510(k) number is K243149.

When did Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) receive FDA 510(k) clearance?

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) received FDA 510(k) clearance on 2024-12-20, under 510(k) number K243149.

Who is the listed applicant for Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)?

The FDA 510(k) record lists Congruence Medical Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)?

The FDA product code for Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) is QLY.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: QLY)

K251849StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc.K243322Altaviz Intravitreal SyringeAltaviz, LLC K243027Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27)Hangzhou Sightnovo Medical Technology Co., Ltd.K243936StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc.K230372VitreJect SyringeOcuject, LLC K200242StaClear SyringeTribofilm Research, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.