Palliare’s Robotic Insufflator Sees Expanded 510(k) Clearance

The FDA has given Palliare’s EVA 15 Insufflator an expanded 510(k) indication for an extended pressure delivery range of up to 25mmHg, often used with patients undergoing bariatric surgery, and to control bleeding during liver surgery.

The robotic insufflator offers continuous pressure insufflation, with integrated smoke evacuation, and is designed for general, laparoscopic and robotic surgeries.

The updated device also offers two levels of insufflation pressure that can be selected hands-free, which is particularly useful when performing emerging endoscopic procedures such as endobariatric, or gastroesophageal reflux disease (GERD), surgeries, the company said.