Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery Guidance for Industry and Food and Drug Administration Staff August 2016
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
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.
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:
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-0218.