Guide on Electrosurgical Device 510(k)s

FDA has issued a final guidance on “Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery.” The agency says that electrosurgical devices used in general surgery are designed to cut and remove tissue and control bleeding through the use of high-frequency electrical current. The electrosurgical devices may also be called radiofrequency devices or high-frequency devices. The document is intended to clarify FDA’s recommendations for thermal damage testing for electrosurgical devices for general surgery.

The guidance applies to electrosurgical devices that may have multiple uses or indications, if one of those indications includes tissue cutting and/or coagulation. In addition, it applies to electrosurgical devices that may include both open and minimally invasive uses, and such devices that are used in arthroscopic procedures.