FDA 510(k)

United Urologics Intermittent Catheter

Номер K: K160795 · 2016-06-16

Дата решения2016-06-16

Код продуктаGBM

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

United Urologics Intermittent Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Robling Medical. It received FDA 510(k) clearance on 2016-06-16 under 510(k) number K160795. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the United Urologics Intermittent Catheter?

United Urologics Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2016-06-16. The listed applicant is Robling Medical. The 510(k) number is K160795.

When did United Urologics Intermittent Catheter receive FDA 510(k) clearance?

United Urologics Intermittent Catheter received FDA 510(k) clearance on 2016-06-16, under 510(k) number K160795.

Who is the listed applicant for United Urologics Intermittent Catheter?

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

What is the FDA product code for United Urologics Intermittent Catheter?

The FDA product code for United Urologics Intermittent Catheter is GBM.

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: GBM)

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited K211436Intermittent Catheter (Not Finalized)Hollister Incorporated K200820SpeediCath Compact SetColoplast K192904SpeediCath Compact SetColoplast K200142SpeediCath SoftColoplast

Официальный источник

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