Clearance Summary
Gynomunal received FDA 510(k) clearance under submission number K143349, sponsored by Polichem S.A. 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 2015-09-16.
- Submission: K143349
- Applicant / Sponsor: Polichem S.A
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2015-09-16
Classification & Regulation
This clearance is catalogued under FDA product code NUC and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.