Clearance Summary
GALILEO DISPOSABLE ENDOSCOPES received FDA 510(k) clearance under submission number K981928, sponsored by Galileo Electro-Optics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1998-08-06.
- Submission: K981928
- Applicant / Sponsor: Galileo Electro-Optics Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1998-08-06
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.