Modular Electromechanical Surgical System

What Is This Device?

A modular electromechanical surgical system is a software-controlled electromechanical system with a plurality of individual, fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures.

How Is SCV Classified?

Modular Electromechanical Surgical System is FDA product code SCV, Class 2, 21 CFR 878.4964.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2026. None was by a company in China. The root cause the FDA records most often is Software design (manufacturing process) (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.