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FDA 510(k)

Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)

Número K: K243367 · 2025-07-22

RequerenteMinnesota Medical Technologies
Data da decisão2025-07-22
Código do produtoPBP
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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