Device Dossier
E21 Series - Electrosurgical system generator, general-purpose
Device Dossier for E21 Series - Electrosurgical system generator, general-purpose (Electrosurgical system generator, general-purpose, Class IIb, sponsor…
- GMDN category: Electrosurgical system generator, general-purpose
Intended purpose
The E21 series is high frequency surgical equipment intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealer/divider devices(E21-B is not applicable) , it is indicated for sealing vessels up to and including 7mm, tissue bundles, and lymphatics. The generator is intended for use in general surgery and such surgical specialties as urologic, vascular, thoracic, gynecologic and colorectal surgery. The device can’t be used in central circuit system/artery and central nervous system.