Clearance Summary
ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY received FDA 510(k) clearance under submission number K890463, sponsored by Critical Specialties, 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 1989-04-07.
- Submission: K890463
- Applicant / Sponsor: Critical Specialties, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.1550
- Decision date: 1989-04-07
Classification & Regulation
This clearance is catalogued under FDA product code HIO and 21 CFR 884.1550, within the Obstetrics/Gynecology review panel as a Class I device.