FDA 510(k)

Phacoemulsification Needle (Tip) and Irrigation Sleeve

Номер K: K192418 · 2020-05-27

ЗаявительRaico, LLC

Дата решения2020-05-27

Код продуктаHQC

Консультативный комитетOP

РешениеSubstantially Equivalent

Описание устройства

Phacoemulsification Needle (Tip) and Irrigation Sleeve is the device name listed in this FDA 510(k) record. The listed applicant is Raico, LLC. It received FDA 510(k) clearance on 2020-05-27 under 510(k) number K192418. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Phacoemulsification Needle (Tip) and Irrigation Sleeve?

Phacoemulsification Needle (Tip) and Irrigation Sleeve is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Raico, LLC. The 510(k) number is K192418.

When did Phacoemulsification Needle (Tip) and Irrigation Sleeve receive FDA 510(k) clearance?

Phacoemulsification Needle (Tip) and Irrigation Sleeve received FDA 510(k) clearance on 2020-05-27, under 510(k) number K192418.

Who is the listed applicant for Phacoemulsification Needle (Tip) and Irrigation Sleeve?

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

What is the FDA product code for Phacoemulsification Needle (Tip) and Irrigation Sleeve?

The FDA product code for Phacoemulsification Needle (Tip) and Irrigation Sleeve is HQC.

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: HQC)

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and Lomb K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, Incorporated K250501System SophiThis AG K243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

Официальный источник

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