Clearance Summary
KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA received FDA 510(k) clearance under submission number K140761, sponsored by Carefusion 2200, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2014-04-21.
- Submission: K140761
- Applicant / Sponsor: Carefusion 2200, Inc.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1300
- Decision date: 2014-04-21
Classification & Regulation
This clearance is catalogued under FDA product code HES and 21 CFR 884.1300, within the Obstetrics/Gynecology review panel as a Class II device.