Clearance Summary
GYNECARE VERSAPOINT G-VAP ELECTRODE received FDA 510(k) clearance under submission number K992901, sponsored by Gynecare, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2000-01-18.
- Submission: K992901
- Applicant / Sponsor: Gynecare, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1690
- Decision date: 2000-01-18
Classification & Regulation
This clearance is catalogued under FDA product code HIH and 21 CFR 884.1690, within the Obstetrics/Gynecology review panel as a Class II device.