Clearance Summary
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 received FDA 510(k) clearance under submission number K051294, sponsored by Femspec LLC. 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 2005-12-21.
- Submission: K051294
- Applicant / Sponsor: Femspec LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1175
- Decision date: 2005-12-21
Classification & Regulation
This clearance is catalogued under FDA product code HHK and 21 CFR 884.1175, within the Obstetrics/Gynecology review panel as a Class II device.