Clearance Summary
SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER received FDA 510(k) clearance under submission number K891290, sponsored by Cook Ob/Gyn. 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 1989-05-23.
- Submission: K891290
- Applicant / Sponsor: Cook Ob/Gyn
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1300
- Decision date: 1989-05-23
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.