Clearance Summary
RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) received FDA 510(k) clearance under submission number K093508, sponsored by Womancare Global. 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 2010-03-04.
- Submission: K093508
- Applicant / Sponsor: Womancare Global
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5070
- Decision date: 2010-03-04
Classification & Regulation
This clearance is catalogued under FDA product code HGH and 21 CFR 884.5070, within the Obstetrics/Gynecology review panel as a Class II device.