FDA Issues 510(k) Clearance for Electrosurgery Generator

Genii has announced it has received 510(k) clearance from FDA to market its new gi4000 electrosurgery generator, according to a news release (pdf).

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The generator uses compact argon technology and is standardizable, according to Genii, a privately held Minnesota corporation.

 

“This generator represents a revolution in ease of use while at the same time provides the power to perform even the most complex procedures,” said Joshua Colton, MD, medical director for Genii and a practicing gastroenterologist in Minnesota, in the release. “It brings the graphical interface into this century — it will do for GI electrosurgery what Apple did for cell phones and personal computers.”

 

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