Clearance Summary
PESSARY received FDA 510(k) clearance under submission number K132313, sponsored by Eis Corporation. 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 2014-12-05.
- Submission: K132313
- Applicant / Sponsor: Eis Corporation
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.3575
- Decision date: 2014-12-05
Classification & Regulation
This clearance is catalogued under FDA product code HHW and 21 CFR 884.3575, within the Obstetrics/Gynecology review panel as a Class II device.