Clearance Summary
GALILEO HYSTEROSCOPES AND LAPAROSCOPES received FDA 510(k) clearance under submission number K962256, sponsored by Galileo Electro-Optics 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 1996-12-06.
- Submission: K962256
- Applicant / Sponsor: Galileo Electro-Optics Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1690
- Decision date: 1996-12-06
Classification & Regulation
This clearance is catalogued under FDA product code HIH and 21 CFR 884.1690, within the Obstetrics/Gynecology review panel as a Class II device.