Clearance Summary
FUJIFILM Endoscope Model EB-710XT received FDA 510(k) clearance under submission number K240075, sponsored by FUJIFILM Healthcare Americas Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2024-02-07.
- Submission: K240075
- Applicant / Sponsor: FUJIFILM Healthcare Americas Corporation
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2024-02-07
Classification & Regulation
This clearance is catalogued under FDA product code EOQ and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.