Clearance Summary
ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M received FDA 510(k) clearance under submission number K991388, sponsored by Pacific Andrology, 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 1999-09-13.
- Submission: K991388
- Applicant / Sponsor: Pacific Andrology, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6130
- Decision date: 1999-09-13
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.