Clearance Summary
IUMC ENDOMETRIAL SAMPLER received FDA 510(k) clearance under submission number K941298, 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 1995-02-13.
- Submission: K941298
- Applicant / Sponsor: Cook Ob/Gyn
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1100
- Decision date: 1995-02-13
Classification & Regulation
This clearance is catalogued under FDA product code HFE and 21 CFR 884.1100, within the Obstetrics/Gynecology review panel as a Class II device.