FDA 510(k)

2-Way 100% Silicone Cleartract Catheter

Номер K: K222118 · 2022-12-01

Дата решения2022-12-01

Код продуктаEZL

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

2-Way 100% Silicone Cleartract Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Silq Technologies, Corp.. It received FDA 510(k) clearance on 2022-12-01 under 510(k) number K222118. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the 2-Way 100% Silicone Cleartract Catheter?

2-Way 100% Silicone Cleartract Catheter is a medical device that received FDA 510(k) clearance on 2022-12-01. The listed applicant is Silq Technologies, Corp.. The 510(k) number is K222118.

When did 2-Way 100% Silicone Cleartract Catheter receive FDA 510(k) clearance?

2-Way 100% Silicone Cleartract Catheter received FDA 510(k) clearance on 2022-12-01, under 510(k) number K222118.

Who is the listed applicant for 2-Way 100% Silicone Cleartract Catheter?

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

What is the FDA product code for 2-Way 100% Silicone Cleartract Catheter?

The FDA product code for 2-Way 100% Silicone Cleartract Catheter is EZL.

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: EZL)

K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLC K232469Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc.

Официальный источник

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