Clearance Summary
FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 received FDA 510(k) clearance under submission number K041903, sponsored by Fujinon, Inc.. 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 2004-11-10.
- Submission: K041903
- Applicant / Sponsor: Fujinon, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2004-11-10
Classification & Regulation
This clearance is catalogued under FDA product code FDF and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.