ALLIANCE RECEIVES 510(K) FOR ULTRASONIC SCALPEL

Alliance Medical, a reprocessor of single-use medical devices, has announced its Reprocessed Ultrasonic Scalpels -- scalpels that utilize ultrasonic energy to enable the cutting and coagulating of soft tissue -- have been cleared by the FDA.

The ultrasonic scalpels are used for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, abdominal, pediatric, gynecologic and other open and endoscopic procedures.

Models in which substantial equivalence was sought have curved, straight and blunt tipped ends and are 5 mm in diameter. Reprocessed ultrasonic scalpels have the same intended use as the original device and do not incorporate new technology, materials or design changes.