Clearance Summary
OTT INSUFFLATION FILTER TUBING received FDA 510(k) clearance under submission number K900878, sponsored by Gynescope Corp.. 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 1990-05-07.
- Submission: K900878
- Applicant / Sponsor: Gynescope Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 1990-05-07
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.