设备，阳痿，机械/液压
PMA编号：P000006 · 2026-08-13
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决定日期2026-08-13
PMA 编号P000006
产品代码FHW
设备分类第3类
医疗专科G
法规编号21 CFR 8
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。
器械摘要
Device, impotence, mechanical/hydraulic is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2026-08-13. The device is classified under product code FHW. It was reviewed by the GU advisory panel.
常见问题
What is the Device, impotence, mechanical/hydraulic?
Device, impotence, mechanical/hydraulic is a medical device that received FDA 510(k) clearance on 2026-08-13. The listed applicant is Coloplast Corp..
When did Device, impotence, mechanical/hydraulic receive FDA 510(k) clearance?
The clearance date for Device, impotence, mechanical/hydraulic can be found in the official FDA records.
设备、阳痿、机械/液压的列名申请人是谁？
The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.
什么是FDA设备产品代码，用于阳痿，机械/液压？
FDA产品代码为器械、阳痿、机械/液压的设备是FHW。
相关临床试验
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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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