Levita Magnetics Snags Class II Status for Gallbladder Surgery Device
The FDA today announced that it reclassified Levita Magnetics’ magnetic surgical system, cleared for gallbladder removal surgeries, as a Class II device.
The system is designed to retract and maneuver the gallbladder using magnetic fields, which the San Mateo, Calif.-based company said “reduces the number of incisions” necessary for the procedure and prevents damage to the abdominal wall.
The company put in a request seeking a class change for the device in February last year, according to an FDA release. The Agency said it reviewed the request and determined that the device can be classified into class II with the establishment of special controls.
The system is designed to retract and maneuver the gallbladder using magnetic fields, which the San Mateo, Calif.-based company said “reduces the number of incisions” necessary for the procedure and prevents damage to the abdominal wall.
The company put in a request seeking a class change for the device in February last year, according to an FDA release. The Agency said it reviewed the request and determined that the device can be classified into class II with the establishment of special controls.