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# Guidance on 510(k)s for Electrosurgical Devices
- URL: https://www.fdaweb.com/guidance-on-510-k-s-for-electrosurgical-devices/
- Published: 2016-08-15T12:00:00.000Z
- Updated: 2026-09-14T21:24:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136503

*Federal Register* Notice: FDA is making available a guidance entitled *Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery.* These devices are designed to cut and/or remove tissue and control bleeding through the use of high-frequency electrical current. For the purpose of this guidance, electrosurgical devices may also be called radiofrequency devices or high-frequency devices. The scope of this document is limited to the Class 2 electrosurgical devices and accessories classified under 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories. To download this guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM389884?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-08-15/pdf/2016-19404.pdf?ref=fdaweb.com)