Cleared Traditional

K261274 - EchoTip Ultra Endobronchial HD Ultrasou...

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

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

K261274 · Cook Ireland, Ltd. · Anesthesiology device
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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 Biopsy Needle (product code FCG), 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 876.1075 - 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

Submission Details

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
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.

Device Classification

Product Code FCG Biopsy Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 - FCG Biopsy Needle

All 50
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K261274.
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
K252646 · Olympus Medical Systems Corp. · Oct 2025
ClearTip FNA and FNB Types
K250994 · Finemedix Co., Ltd. · Aug 2025
EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)
K241209 · Cook Ireland, Ltd. · Jul 2024
Precision GI
K231422 · Limaca Medical, Ltd. · Aug 2023
ClearTip
K231267 · Finemedix Co., Ltd. · Jun 2023
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
K230909 · Cook Ireland, Ltd. · May 2023