Clearance Summary
BIOPSY PIPETTES received FDA 510(k) clearance under submission number K133257, sponsored by Research Instruments , Ltd.. 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 2014-05-16.
- Submission: K133257
- Applicant / Sponsor: Research Instruments , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6130
- Decision date: 2014-05-16
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.