Cleared Traditional

K142688 - Echotip Procore HD Ultrasound Biopsy Needle

K142688 is an FDA 510(k) clearance for Echotip Procore HD Ultrasound Biopsy Needle, manufactured by Cook Ireland, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K142688 · Cook Ireland, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
88d
Days
Class 2
Risk

K142688 is an FDA 510(k) clearance for the Echotip Procore HD Ultrasound Biopsy Needle. 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 December 19, 2014 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Ireland, Ltd. devices

FDA 510(k) Submission Details - K142688

510(k) Number K142688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2014
Decision Date December 19, 2014
Days to Decision 88 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
43d faster than avg
Panel avg: 131d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCG Device Classification - Class 2, Special Controls

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 85
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K142688.
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K151895 · Boston Scientific Corporation · Oct 2015
Corvocet Coaxial Introducer
K151373 · Merit Medical Systems, Inc. · Aug 2015
BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
K150891 · Covidien, LLC( Formerly Beacon Endoscopic Corp.) · May 2015
HS NOTA
K131925 · H.S. Hospital Services S.P.A. · Oct 2014
SHARKCORE FINE NEEDLE BIOPSY SYSTEM
K141894 · Covidien, LLC( Formerly Beacon Endoscopic Corp.) · Oct 2014
SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM
K133763 · Medi-Globe Corporation · May 2014