Clearance Summary
ELRAN 01 SYSTEM received FDA 510(k) clearance under submission number K002431, sponsored by Envision Advanced Medical System, Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2000-10-24.
- Submission: K002431
- Applicant / Sponsor: Envision Advanced Medical System, Ltd.
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2000-10-24
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.