FDA Clears Pediatric Vessel Sealing System

FDA has cleared a JustRight Surgical 510(k) for specific use of its 3mm JustRight Vessel Sealing System in pediatric surgery. “JustRight Surgical is the first and only company to secure clearance from the FDA for an electrosurgical device to be used specifically for pediatric patients,” the company says. The clearance was based on clinical data that was presented at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) clinical congress in May.

The device was shown to be safe to use in extremely tight or small spaces found in teens, children, infants and neonates, the company says. “The new, low-power vessel sealing technology was found to permanently fuse vessels while using significantly less energy and was therefore determined to be safe to use in the smallest patients without risk of damaging critical, adjacent structures,” it says.