Clearance Summary
OVARIAN ASPIRATION/IRRIGATION NEEDLE received FDA 510(k) clearance under submission number K910579, 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 1991-02-28.
- Submission: K910579
- Applicant / Sponsor: Marlo Surgical Technology
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 1991-02-28
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.