Clearance Summary
MANIPUSEAL received FDA 510(k) clearance under submission number K051160, sponsored by Insitu Systems. 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 2005-09-02.
- Submission: K051160
- Applicant / Sponsor: Insitu Systems
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1640
- Decision date: 2005-09-02
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.