Regulator
Under 510(k) clearance K252675, the FDA cleared da Vinci SP for nipple-sparing mastectomy, a breast cancer operation.
A regulator's decision · Sets da Vinci SP's stage
What the source says
“The subsequent issuance of K252675 has exacerbated those concerns and warrants immediate agency action.”
What it means
da Vinci SP, from Intuitive, is at stage 5 of 5 on our ladder: regulator-cleared or mass market. This event is one of the milestones that placed it there.
Human help: A surgeon in the operating room controls it; it doesn't operate on its own.
More on da Vinci SP
- Two professors filed a petition asking the FDA to remove the robotic mastectomy use until long-term cancer safety data exist.
- The FDA cleared da Vinci SP for groin hernia repair, gallbladder removal and appendix removal.
- Intuitive started a Class 2 recall of SP instrument arm drapes (sterile covers), which could come loose from the robot arm.
- The FDA cleared da Vinci SP for colorectal (bowel) surgery.
- The FDA cleared da Vinci SP for more prostate operations, including removal of the whole prostate through the bladder.
- The FDA cleared da Vinci SP for ear, nose and throat surgery done through the mouth.