Clearance Summary
CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATOR received FDA 510(k) clearance under submission number K914101, sponsored by Circon Video. 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 1991-11-22.
- Submission: K914101
- Applicant / Sponsor: Circon Video
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 1991-11-22
Classification & Regulation
This clearance is catalogued under FDA product code HIF and 21 CFR 884.1730, within the Obstetrics/Gynecology review panel as a Class II device.