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FDA 510(k)

Wellead®亲水性间歇导尿管即用型；Wellead®亲水性间歇导尿管紧凑型

K号: K241734 · 2025-03-05

申请人Well Lead Medical Co., Ltd.
决定日期2025-03-05
产品代码GBM
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-03-05 under 510(k) number K241734. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact?

Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact is a medical device that received FDA 510(k) clearance on 2025-03-05. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K241734.

When did Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact receive FDA 510(k) clearance?

Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact received FDA 510(k) clearance on 2025-03-05, under 510(k) number K241734.

Who is the listed applicant for Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact?

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

What is the FDA product code for Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact?

The FDA product code for Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact is GBM.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Well Lead Medical Co., Ltd.为申报人的其他记录

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。

K220722PVC 亲水性尿道导管K220036Wellead 肾盂导管K211543魏鼻喷管K211814Wellead 内窥镜密封装置K202134Well Lead All 硅胶 Foley 导尿管带温度传感器K203119ClearPetra 吸引-排空套管

查看所有 12 个设备 →

相关器械（代码：GBM）

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。

K213283GentleCath Air for Men 水性间歇性导尿管Convatec LimitedK211436间歇性导尿管（未最终确定）Hollister IncorporatedK200820SpeediCath Compact 套件ColoplastK192904SpeediCath Compact 套件ColoplastK200142SpeediCath 软ColoplastK200134吉姆氏一次性无菌尿道导管Hangzhou Jimushi Meditech Co., Ltd.

官方来源

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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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