Clearance Summary
ColpoWave Colpotomizer and CerviGrip Uterine Manipulator received FDA 510(k) clearance under submission number K161065, sponsored by Surgitools Pty , 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 2016-10-27.
- Submission: K161065
- Applicant / Sponsor: Surgitools Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1640
- Decision date: 2016-10-27
Classification & Regulation
This clearance is catalogued under FDA product code HEW and 21 CFR 884.1640, within the Obstetrics/Gynecology review panel as a Class II device.