Minnesota Medical Technologies Announces FDA 510(k) Clearance for its Fecal Incontinence Device

STEWARTVILLE, Minn., July 24, 2025 /PRNewswire/ -- Minnesota Medical Technologies, today announced that it received FDA 510(k) clearance for its fecal incontinence device ("StaySure(™)").

The disposable, easy to use, self-inserted StaySure fecal incontinence insert is a breakthrough in the management of fecal incontinence and accidental bowel leakage. The innovation lies in its adaptability. Made from 100% silicone and filled with an encased fluid, StaySure is specially crafted to conform to your body as you move throughout the day. Its soft silicone shaft, flexible structure, and supple external retainer ensure a secure fit without compromising comfort.

David A. Jonas, CEO of Minnesota Medical Technologies, commented: “We are thrilled to have received U.S. regulatory clearance for StaySure, and I want to congratulate our product development and regulatory teams for their excellent work in achieving this important milestone for the company.

Fecal Incontinence (FI) and Accidental Bowel Leakage (ABL) are conditions endured by millions of people in the United States alone. StaySure is a true breakthrough in the management of FI and ABL—and represents the first truly practical and effective solution for many of those living with these challenging conditions. We are excited to bring this product to the people who need it most.” 

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