FDA 510(k)

Unicare System, Unicare Manipulator

Номер K: K163214 · 2017-02-07

Дата решения2017-02-07

Код продуктаLKF

Консультативный комитетOB

РешениеSubstantially Equivalent

Описание устройства

Unicare System, Unicare Manipulator is the device name listed in this FDA 510(k) record. The listed applicant is Clearpath Surgical, Inc.. It received FDA 510(k) clearance on 2017-02-07 under 510(k) number K163214. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Unicare System, Unicare Manipulator?

Unicare System, Unicare Manipulator is a medical device that received FDA 510(k) clearance on 2017-02-07. The listed applicant is Clearpath Surgical, Inc.. The 510(k) number is K163214.

When did Unicare System, Unicare Manipulator receive FDA 510(k) clearance?

Unicare System, Unicare Manipulator received FDA 510(k) clearance on 2017-02-07, under 510(k) number K163214.

Who is the listed applicant for Unicare System, Unicare Manipulator?

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

What is the FDA product code for Unicare System, Unicare Manipulator?

The FDA product code for Unicare System, Unicare Manipulator is LKF.

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: LKF)

K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.K252260RELIEEV HSG Catheter (HSG7FA1)Li Medical Corporation , Ltd.K242002FemVue MINI Saline-Air DeviceFemasys, Inc.K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation , Ltd.K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.K222798Rejoni Intrauterine CatheterRejoni, Inc.

Официальный источник

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