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

New FDA clearance opens the US market for Stewartville medical device maker

STEWARTVILLE, Minn. — Clearance by the Food and Drug Administration means a Stewartville manufacturer can now sell its fecal incontinence devices in the US, after years of being limited to the European market. “It is a very big deal. A lot of blood, sweat, tears and money have been shed over the last eight years to get here,” said Minnesota Medical Technologies CEO and President David Jonas. “The U.S. and Europe have virtually the same populatio…

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(™)").