date:May 04, 2012
that are novel and not substantially equivalent to any legally marketed device. The Percutaneous Surgical Set represents the fourth device granted a de novo petition this year.
The FDA granted the de novo petition based on data provided by the sponsor showing that the device functions as intended, and is properly sized for laparoscopic abdominal surgery, and surgeons can apply enough force to grasp and manipulate soft tissue. The sponsor also conducted studies to collect data on the ability of s