Clearance Summary
LEICA COLPOSCOPE received FDA 510(k) clearance under submission number K000707, sponsored by Leica Microscopy Systems , Ltd.. 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 2000-06-27.
- Submission: K000707
- Applicant / Sponsor: Leica Microscopy Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1630
- Decision date: 2000-06-27
Classification & Regulation
This clearance is catalogued under FDA product code HEX and 21 CFR 884.1630, within the Obstetrics/Gynecology review panel as a Class II device.