In Brief: Gynecare
This article was originally published in The Gray Sheet
Executive Summary
Gynecare: Gains 510(k) clearance for the VersaPoint hysteroscopic fibroid removal system. Intended as an alternative to hysterectomy, the minimally invasive device utilizes "proprietary bipolar electro-vaporization technology" to "vaporize, cut or desiccate" uterine fibroids, which Gynecare says account for approximately 30% of the more than 600,000 hysterectomies performed annually in the U.S. Menlo Park, California-based Gynecare filed a 510(k) for the device in June ("The Gray Sheet" July 1, In Brief)...