硅胶尿道导管（硅胶尿道导管）
K号: K243011 · 2025-06-16
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决定日期2025-06-16
产品代码EZL
咨询委员会GU
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决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：EZL）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K260756创伤卫士腹部压力感应系统（000-0221）Sentinel Medical Technologies,K262056Rusch 液体金福来尿管Teleflex Medical Sdn. Bhd.K252537Rusch 软塑 Foley 导尿管Teleflex Medical Sdn. Bhd.K241424InnoCare 专业 Foley 导尿管Innocare Urologics, LLCK232469Rüsch 橡胶金 Foley 导尿管Teleflexmedical, Inc.K240057创伤卫士腹腔压力感应系统Sentinel Medical Technologies, LLC
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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