Cleared Traditional

K210476 - EchoTip Ultra Endoscopic Ultrasound Needle

K210476 is the FDA 510(k) clearance for EchoTip Ultra Endoscopic Ultrasound Needle by Cook Ireland, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FCG) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K210476 · Cook Ireland, Ltd. · Gastroenterology & Urology device
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May 2021
Decision
90d
Days
Class 2
Risk

K210476 is an FDA 510(k) clearance for the EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Bio.... 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 May 20, 2021 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Ireland, Ltd. devices

Submission Details

510(k) Number K210476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2021
Decision Date May 20, 2021
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FCG Biopsy Needle

All 49
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K210476.
EndoDrill® Model X
K212423 · Bibbinstruments AB · Mar 2023
Disposable Biopsy Refill Needle
K212819 · Suzhou Leapmed Healthcare Corporation · Jul 2022
Disposable Coaxial Biopsy Needle
K212822 · Suzhou Leapmed Healthcare Corporation · Jul 2022
Biopsy Needle
K191472 · Ushare Medical, Inc. · Jan 2020
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
K181756 · Apriomed AB · Dec 2018
Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
K180668 · Olympus Medical Systems Corp. · Nov 2018