Applied Medical Technology (AMT) has received 510(k) clearance from the U.S. Food and Drug Administration for a new feeding tube.
Cleveland area AMT’s “Low-Profile Transgastric-Jejunal Feeding Tube Kit” was listed among the FDA’s 510(k) clearances for October. Company official Dr. George Picha didn’t return a call seeking comment.
The jejunum, which is referenced in the product’s name, is the middle section of the small intestine.
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AMT specializes in enteral feeding, a method for delivering liquid nutrients to the stomach or intestines. One of its latest products is the Mini ONE Button, a feeding tube that it says covers more surface area and minimizes leaks better than other alternatives on the market.
For AMT, the product clearance was slightly more welcome news from the FDA than what came from the agency earlier this year. In June, the FDA published a warning letter that it had sent to AMT over manufacturing and design issues at its suburban Cleveland location.
