Clearance Summary
IOGYN SYSTEM received FDA 510(k) clearance under submission number DEN130040, sponsored by Iogyn, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2014-03-28.
- Submission: DEN130040
- Applicant / Sponsor: Iogyn, Inc.
- Clearance pathway: Direct
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1710
- Decision date: 2014-03-28
Classification & Regulation
This clearance is catalogued under FDA product code PGT and 21 CFR 884.1710, within the Obstetrics/Gynecology review panel as a Class II device.