Clearance Summary
EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes received FDA 510(k) clearance under submission number K261274, sponsored by Cook Ireland, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2026-07-24.
- Submission: K261274
- Applicant / Sponsor: Cook Ireland, Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2026-07-24
Classification & Regulation
This clearance is catalogued under FDA product code KTI and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.