Clearance Summary
FUJIFILM ENDOSCOPIC CO2 REGULATOR received FDA 510(k) clearance under submission number K133976, sponsored by Fujifilm Medical System 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 2014-09-09.
- Submission: K133976
- Applicant / Sponsor: Fujifilm Medical System U.S.A., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2014-09-09
Classification & Regulation
This clearance is catalogued under FDA product code FCX and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.