Clearance Summary
INSUFFLATOR TUBING/FILTER KIT received FDA 510(k) clearance under submission number K922244, sponsored by O.R. Concepts, 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 1993-09-24.
- Submission: K922244
- Applicant / Sponsor: O.R. Concepts, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 1993-09-24
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.