Clearance Summary
EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip received FDA 510(k) clearance under submission number K161275, sponsored by Research Instruments Limited. 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 2017-01-23.
- Submission: K161275
- Applicant / Sponsor: Research Instruments Limited
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6130
- Decision date: 2017-01-23
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.