https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarket-notification-510k-submissions-electrosurgical-devices-general-surgery?utm_campaign=2020-03-09%20Updated%20Guidance%20on%20510%28k%29%20for%20Electrosurgical%20Devices%20for%20General%20Surgery&utm_medium=email&utm_source=Eloqua

FDA Issues Updated Guidance on 510(k) for Electrosurgical Devices for General Surgery

Today, the U.S. Food and Drug Administration (FDA) issued an update to the guidance: Premarket Notification Submission for Electrosurgical Devices for General Surgery to assist device manufacturers with completing premarket notification (510k)) submissions.  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 (RF) devices or high-frequency (HF) devices.  This updated guidance clarifies the FDA’s recommendations for thermal damage testing for electrosurgical devices for general surgery.

Read the Guidance Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education.