FDA 510(k)

StaClear Syringe

Номер K: K200242 · 2020-07-27

Дата решения2020-07-27

Код продуктаQLY

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

StaClear Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Tribofilm Research, Inc.. It received FDA 510(k) clearance on 2020-07-27 under 510(k) number K200242. 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 StaClear Syringe?

StaClear Syringe is a medical device that received FDA 510(k) clearance on 2020-07-27. The listed applicant is Tribofilm Research, Inc.. The 510(k) number is K200242.

When did StaClear Syringe receive FDA 510(k) clearance?

StaClear Syringe received FDA 510(k) clearance on 2020-07-27, under 510(k) number K200242.

Who is the listed applicant for StaClear Syringe?

The FDA 510(k) record lists Tribofilm Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StaClear Syringe?

The FDA product code for StaClear Syringe 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.K243149Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)Congruence Medical Solutions, LLC K230372VitreJect SyringeOcuject, LLC

Официальный источник

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