Clearance Summary
FUJIFILM Ultrasonic Endoscope received FDA 510(k) clearance under submission number K182825, sponsored by Fujifilm 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 2019-02-22.
- Submission: K182825
- Applicant / Sponsor: Fujifilm Corporation
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2019-02-22
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.