Cleared Traditional

K261274 - EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes

Also marketed or referenced as:
EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes

K261274 is an FDA 510(k) clearance for EchoTip Ultra Endobronchial HD Ultrasou..., manufactured by Cook Ireland, Ltd.. The device is a Class 2 Anesthesiology device with product code KTI cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K261274 · Cook Ireland, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
98d
Days
Class 2
Risk

K261274 is an FDA 510(k) clearance for the EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes. Classified as Bronchoscope Accessory (product code KTI), Class II - Special Controls.

Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on July 24, 2026 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 874.4680 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Ireland, Ltd. devices

FDA 510(k) Submission Details - K261274

510(k) Number K261274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2026
Decision Date July 24, 2026
Days to Decision 98 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 140d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTI Device Classification - Class 2, Special Controls

Product Code KTI Bronchoscope Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - KTI Bronchoscope Accessory

All 31
Devices cleared under the same product code (KTI) and FDA review panel - the closest regulatory comparables to K261274.
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