Clearance Summary
MEDICON MOGEN CLAMP received FDA 510(k) clearance under submission number K100916, sponsored by Medicon EG. 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 2010-12-06.
- Submission: K100916
- Applicant / Sponsor: Medicon EG
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2010-12-06
Classification & Regulation
This clearance is catalogued under FDA product code HFX and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.