Clearance Summary
LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES received FDA 510(k) clearance under submission number K111014, sponsored by Lsi Solutions, Inc.. 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 2012-07-13.
- Submission: K111014
- Applicant / Sponsor: Lsi Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1640
- Decision date: 2012-07-13
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.