明尼苏达医疗技术粪便失禁插入物（My Miracle）
K号: K243367 · 2025-07-22
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决定日期2025-07-22
产品代码PBP
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
Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) is the device name listed in this FDA 510(k) record. The listed applicant is Minnesota Medical Technologies. It received FDA 510(k) clearance on 2025-07-22 under 510(k) number K243367. The device is classified under product code PBP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)?
Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) is a medical device that received FDA 510(k) clearance on 2025-07-22. The listed applicant is Minnesota Medical Technologies. The 510(k) number is K243367.
When did Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) receive FDA 510(k) clearance?
Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) received FDA 510(k) clearance on 2025-07-22, under 510(k) number K243367.
Who is the listed applicant for Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)?
The FDA 510(k) record lists Minnesota Medical Technologies as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)?
The FDA product code for Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) is PBP.
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官方来源
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