FDA 510(k)

Silicone Urethral Catheter (Silicone Urethral Catheter)

Номер K: K243011 · 2025-06-16

ЗаявительGuangdong Ecan Medical Co., Ltd.

Дата решения2025-06-16

Код продуктаEZL

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Silicone Urethral Catheter (Silicone Urethral Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Ecan Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-06-16 under 510(k) number K243011. 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 Silicone Urethral Catheter (Silicone Urethral Catheter)?

Silicone Urethral Catheter (Silicone Urethral Catheter) is a medical device that received FDA 510(k) clearance on 2025-06-16. The listed applicant is Guangdong Ecan Medical Co., Ltd.. The 510(k) number is K243011.

When did Silicone Urethral Catheter (Silicone Urethral Catheter) receive FDA 510(k) clearance?

Silicone Urethral Catheter (Silicone Urethral Catheter) received FDA 510(k) clearance on 2025-06-16, under 510(k) number K243011.

Who is the listed applicant for Silicone Urethral Catheter (Silicone Urethral Catheter)?

The FDA 510(k) record lists Guangdong Ecan Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Silicone Urethral Catheter (Silicone Urethral Catheter)?

The FDA product code for Silicone Urethral Catheter (Silicone Urethral 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.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLC K232469Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc.K240057TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC

Официальный источник

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