CDRH Industry: Announcing Two Guidances Regarding Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers and Electrosurgical Devices for General Surgery

Today, the U.S. Food and Drug Administration released two final guidance documents:

Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery

FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for bipolar electrosurgical vessel sealers intended for use in general surgery. These devices are designed to seal isolated blood and lymphatic vessels for hemostasis (as an alternative to ties) through the use of high-frequency electrical current between two electrodes in close proximity.

Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery

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.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health