Clearance Summary
IMT LOUPE-COLPOSCOPE received FDA 510(k) clearance under submission number K963593, sponsored by Inventive Medical Technology. 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 1997-04-22.
- Submission: K963593
- Applicant / Sponsor: Inventive Medical Technology
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1630
- Decision date: 1997-04-22
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.