Clearance Summary
BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA received FDA 510(k) clearance under submission number K921722, sponsored by Bard Reproductive Systems. 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 1994-05-02.
- Submission: K921722
- Applicant / Sponsor: Bard Reproductive Systems
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 1994-05-02
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.