Fidmi Medical received 510(k) clearance for its low-profile enteral feeding device, a gastronomy tube designed to deliver nutrients to patients.

The device can be used for initial placement as well as replacement and features an inner tube that is easily replaceable by patients at home, eliminating the need to visit healthcare facilities for replacement procedures.

The company noted that complications from gastronomy tubes are common and tube replacements are often necessary due to clogging and dislodgements.