DeviceClearance

EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes +1 more— 510(k) K261274

Substantially Equivalent

Cook Ireland, Ltd.

FDA 510(k) clearance K261274 for EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes +1 more, Substantially Equivalent on 2026-07-24. Applicant: Cook Ireland, Ltd.. Device class: 2.

Summary

Cook Ireland's clearance covers the EchoTip Ultra and EchoTip ProCore Endobronchial HD Ultrasound Biopsy Needles, both named for Fujifilm scopes. They're filed under KTI, bronchoscope accessories, and the record doesn't give needle gauges.

Class II, 21 CFR 874.4680. The Anesthesiology review panel handled it as a Traditional 510(k), though the record lists Ear, Nose, and Throat as the classification panel.

Cook Ireland filed from Limerick, Ireland. Review took 98 calendar days (April 17 to July 24, 2026).

Clearance details

Device name as filed
EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes
Applicant
Cook Ireland, Ltd.
Product code
Product code KTI
Device class
Class 2
Regulation
21 CFR 874.4680
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Limerick, IE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KTI

product code KTI
Malfunction
642
Total
642

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.