Cleared Traditional

K141894 - SHARKCORE FINE NEEDLE BIOPSY SYSTEM

K141894 is an FDA 510(k) clearance for SHARKCORE FINE NEEDLE BIOPSY SYSTEM, manufactured by Covidien, LLC( Formerly Beacon Endoscopic Corp.). The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K141894 · Covidien, LLC( Formerly Beacon Endoscopic Corp.) · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K141894

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 131d · This submission: 84d
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 K141894.
BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
K150891 · Covidien, LLC( Formerly Beacon Endoscopic Corp.) · May 2015
Echotip Procore HD Ultrasound Biopsy Needle
K142688 · Cook Ireland, Ltd. · Dec 2014
HS NOTA
K131925 · H.S. Hospital Services S.P.A. · Oct 2014
SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM
K133763 · Medi-Globe Corporation · May 2014
SAFETY BIOPSY NEEDLE SYSTEM
K140137 · Pfm Medical, Inc. · Mar 2014
BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,
K133008 · Beacon Endoscopic · Nov 2013