Clearance Summary
PRECISION CAPILLARIES FOR MICROMANIPULATION received FDA 510(k) clearance under submission number K024302, sponsored by Brinkmann Instruments, 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 2003-02-19.
- Submission: K024302
- Applicant / Sponsor: Brinkmann Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6130
- Decision date: 2003-02-19
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.