设备，失禁，机械/液压
PMA编号：P000053 · 2026-09-14
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决定日期2026-09-14
PMA 编号P000053
产品代码EZY
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, incontinence, mechanical/hydraulic is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2026-09-14. The device is classified under product code EZY. It was reviewed by the GU advisory panel.
常见问题
What is the Device, incontinence, mechanical/hydraulic?
Device, incontinence, mechanical/hydraulic is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is Boston Scientific Corp.
When did Device, incontinence, mechanical/hydraulic receive FDA 510(k) clearance?
The clearance date for Device, incontinence, mechanical/hydraulic can be found in the official FDA records.
Who is the listed applicant for Device, incontinence, mechanical/hydraulic?
The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Device, incontinence, mechanical/hydraulic?
The FDA product code for Device, incontinence, mechanical/hydraulic is EZY.
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官方来源
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