Clearance Summary
BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES received FDA 510(k) clearance under submission number K092554, 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 2010-04-30.
- Submission: K092554
- Applicant / Sponsor: Sunlight Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6130
- Decision date: 2010-04-30
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.