Clearance Summary
FERTILOSCOPY KIT FH 1.29/FTO 1.40 received FDA 510(k) clearance under submission number K992655, sponsored by Soprane S.A.. 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 2000-03-13.
- Submission: K992655
- Applicant / Sponsor: Soprane S.A.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1640
- Decision date: 2000-03-13
Classification & Regulation
This clearance is catalogued under FDA product code HEW and 21 CFR 884.1640, within the Obstetrics/Gynecology review panel as a Class II device.