Clearance Summary
ENDOSCOPIC LIGHT SOURCE 250 ENDO received FDA 510(k) clearance under submission number K903790, sponsored by Orlux Engineering and Instrumentation. 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 1990-12-07.
- Submission: K903790
- Applicant / Sponsor: Orlux Engineering and Instrumentation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1990-12-07
Classification & Regulation
This clearance is catalogued under FDA product code FCW and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.