Clearance Summary
ICSI-100 received FDA 510(k) clearance under submission number K043116, sponsored by Vitrolife Sweden AB. 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 2005-01-13.
- Submission: K043116
- Applicant / Sponsor: Vitrolife Sweden AB
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2005-01-13
Classification & Regulation
This clearance is catalogued under FDA product code MQL and 21 CFR 884.6180, within the Obstetrics/Gynecology review panel as a Class II device.