Clearance Summary
INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES received FDA 510(k) clearance under submission number K072600, sponsored by Sunlight Medical, Inc.. 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 2008-05-19.
- Submission: K072600
- Applicant / Sponsor: Sunlight Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6130
- Decision date: 2008-05-19
Classification & Regulation
This clearance is catalogued under FDA product code MQH and 21 CFR 884.6130, within the Obstetrics/Gynecology review panel as a Class II device.