Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff

Issue Date: March 9, 2020
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Clinical – Medical, Good Clinical Practice (GCP), Labeling, General & Plastic Surgery
Status: Final

Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff

FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for electrosurgical devices intended for use in 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 (RF) devices or high-frequency (HF) devices.

Download the Guidance Document