Clearance Summary
OTT INSUFFLATOR FILTER PLUS/TUBING SET received FDA 510(k) clearance under submission number K914153, sponsored by Marlo Surgical Technology. 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 1992-04-02.
- Submission: K914153
- Applicant / Sponsor: Marlo Surgical Technology
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 1992-04-02
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.