Some medical devices have a 510(k) number. What is this and do ADC devices have a 510(k) number?

A 510(k) number is a premarket notification number that is required for certain classes of medical devices in the US. Generally, devices that are higher risk require premarket notification to the FDA prior to bringing the devices to market. The 510(k) number is issued once a company has proven that a device is substantially equivalent in performance and safety to other devices already existing on the market. ADC manufactures and distributes a number of devices that require premarket notification, and the 510(k) numbers for these devices are available from our regulatory department. It should be noted that devices with less risk are often exempt from the premarket notification requirements.