What is the FDA 510(k) clearance for surgical robots ?

Several surgical robots get the FDA 510(k) clearance, which means they are proven to be equivalent to the already-approved surgical techniques.

Here is a story behind the FDA approval.  ISS could not get through  FDA approval procedures because they claimed their surgical robot, robodoc, used a new kind of surgical techniques. They changed their claim and applied for the FDA 510(k). Finally,  they got the FDA approval.   The FDA 510(k) document of the robodoc can be found at the following link: 


Since the robodoc succeeded in getting the FDA 510(k), other surgical robots including da Vinci  have followed the FDA 510(k) approval path.

What is the inconvenient truth that medical robot companies and hospitals will never tell you ?

Do you really want to know this ? 

Please go to the  FDA web page and look at the FDA approval documents of  medical robots.

Informally speaking,  FDA approval is given to the specific-application of a medical robot, not the medical robot itself. That means if a hospital buys a medical robot and does whatever-we-want  surgeries, it violates FDA regulations.