Clearance Summary
FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 received FDA 510(k) clearance under submission number K042043, 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 2004-11-24.
- Submission: K042043
- Applicant / Sponsor: Fujinon, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2004-11-24
Classification & Regulation
This clearance is catalogued under FDA product code FDS and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.