The FDA recently approved marketing for the first surgical device that can be assembled and disassembled within the body, according to a press release.
The Percutaneous Surgical Set (Ethicon Endo-Surgery) is intended for minimally invasive laparoscopic abdominal surgery. Potential risks include tissue inflammation, infection, abdominal cavity damage, device failure and user error, the release said.
“Laparoscopic surgery reduces the size and number of incisions needed to perform certain surgical procedures,” Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in the release. “The Percutaneous Surgical Set provides a novel treatment option for performing this type of abdominal procedure.”
The surgical set is the fourth device this year to receive approval through de novo classification, which is intended for medical devices with low-to-moderate risk that are not equivalent to other marketed devices. The petition was granted based on data indicating proper function of the device and that it is appropriately sized for laparoscopic abdominal surgery.