Clearance Summary
VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION received FDA 510(k) clearance under submission number K882956, sponsored by Vital Metrics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1988-08-03.
- Submission: K882956
- Applicant / Sponsor: Vital Metrics, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 1988-08-03
Classification & Regulation
This clearance is catalogued under FDA product code HBI and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.