Clearance Summary
LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR received FDA 510(k) clearance under submission number K905747, sponsored by Coopervision Surgical. 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 1991-09-17.
- Submission: K905747
- Applicant / Sponsor: Coopervision Surgical
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4120
- Decision date: 1991-09-17
Classification & Regulation
This clearance is catalogued under FDA product code HGI and 21 CFR 884.4120, within the Obstetrics/Gynecology review panel as a Class II device.