Clearance Summary
EPX-4440FN Digital Video Processor with Light Source received FDA 510(k) clearance under submission number K180414, sponsored by Fujifilm New Development U.S.A., 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 2018-05-24.
- Submission: K180414
- Applicant / Sponsor: Fujifilm New Development U.S.A., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2018-05-24
Classification & Regulation
This clearance is catalogued under FDA product code FET and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.