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GUIDANCE DOCUMENT

Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff March 2020

Download the Final Guidance Document
Final
Docket Number:
FDA-2014-D-0217
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-0217.

 
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