Clearance Summary
ACKRAD H/S PROCEDURE TRAY received FDA 510(k) clearance under submission number K881680, sponsored by Ackrad Laboratories. 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 1988-07-15.
- Submission: K881680
- Applicant / Sponsor: Ackrad Laboratories
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1700
- Decision date: 1988-07-15
Classification & Regulation
This clearance is catalogued under FDA product code HIG and 21 CFR 884.1700, within the Obstetrics/Gynecology review panel as a Class II device.