Cleared Traditional

K141894 - SHARKCORE FINE NEEDLE BIOPSY SYSTEM (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141894 · Covidien, LLC( Formerly Beacon Endoscopic Corp.) · Gastroenterology & Urology device
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Oct 2014
Decision
84d
Days
Class 2
Risk

K141894 is an FDA 510(k) clearance for the SHARKCORE FINE NEEDLE BIOPSY SYSTEM. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Covidien, LLC( Formerly Beacon Endoscopic Corp.) (Auburndale, US). The FDA issued a Cleared decision on October 6, 2014 after a review of 84 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 Covidien, LLC( Formerly Beacon Endoscopic Corp.) devices

Submission Details

510(k) Number K141894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2014
Decision Date October 06, 2014
Days to Decision 84 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 130d · This submission: 84d
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 132
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K141894.
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ClearTip
K231267 · Finemedix Co., Ltd. · Jun 2023
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
K230909 · Cook Ireland, Ltd. · May 2023