Clearance Summary
KEGEL SMART, KEGELSMART PEARL received FDA 510(k) clearance under submission number K140780, sponsored by Regulatory Insight, 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 2014-09-10.
- Submission: K140780
- Applicant / Sponsor: Regulatory Insight, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1425
- Decision date: 2014-09-10
Classification & Regulation
This clearance is catalogued under FDA product code HIR and 21 CFR 884.1425, within the Obstetrics/Gynecology review panel as a Class II device.