K261274
- 510(k) number
- K261274
- Device name
- EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes
- Applicant
- Cook Ireland, Ltd. IE
- Product code
- KTI — Bronchoscope Accessory
- Decision date
- 2026-07-24
- Date received
- 2026-04-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K261274.pdf
Official FDA record: K261274
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.