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FDA 510(k)

Altis单切口悬吊系统（519650）；Aris经闭孔悬吊系统（519551）；Supris经耻骨悬吊系统（519562）

K号: K242473 · 2024-10-18

申请人Coloplast Corp.
决定日期2024-10-18
产品代码PAH
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决定实质等同

器械摘要

Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K242473. The device is classified under product code PAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)?

Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Coloplast Corp.. The 510(k) number is K242473.

When did Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) receive FDA 510(k) clearance?

Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) received FDA 510(k) clearance on 2024-10-18, under 510(k) number K242473.

Who is the listed applicant for Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)?

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

What is the FDA product code for Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)?

The FDA product code for Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) is PAH.

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Coloplast Corp.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。

K252140Heylo™ SystemK251116Luja 弯头K250270Luja SetK242049SureCath SetK241210Luja 弯头K242173Retrace输尿管通道鞘（ASXL10，ASXL12，ACXL10，ACXL12，AXXL10，AXXL12，ALXL10，ALXL12）

查看所有 25 个设备 →

相关器械（代码：PAH）

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。

K221874Altis单切口悬吊系统Coloplast A/SK191416Desara One 单切口吊带系统，1 套；Desara One 单切口吊带系统，3 套Caldera Medical, Inc.

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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