FDA 510(k)

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

Номер K: K243149 · 2024-12-20

ЗаявительCongruence Medical Solutions, LLC

Дата решения2024-12-20

Код продуктаQLY

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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.

Официальный источник

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