Clearance Summary
Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T received FDA 510(k) clearance under submission number K143556, sponsored by Fujifilm Medical Systems 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 2015-08-20.
- Submission: K143556
- Applicant / Sponsor: Fujifilm Medical Systems U.S.A, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2015-08-20
Classification & Regulation
This clearance is catalogued under FDA product code FDA and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.