Gynecare files with FDA for 510(k) clearance of bipolar vaporization system for fibroid removal.

Business Wire | June 26, 1996 | Copyright

MENLO PARK, Calif.--(HealthWire)--June 26, 1996-- Gynecare(TM), Inc. (NASDAQ: GYNE), a supplier of innovative and cost-effective medical devices for the treatment of uterine disorders, today announced that it has filed with the U.S. Food and Drug Administration for 510(k) market clearance of the Bipolar Vaporization system for fibroid removal. The Bipolar Vaporization system is designed to reduce the risks of traditional surgical fibroid removal procedures through the use of novel, electro-vaporization technology.

Fibroids are a leading cause of hysterectomy (surgical ...

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