Cleared Special

K040893 - EASY CORE BIOPSY SYSTEM

K040893 is an FDA 510(k) clearance for EASY CORE BIOPSY SYSTEM, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Special 510(k) pathway after a 30-day FDA review.

K040893 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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May 2004
Decision
30d
Days
Class 2
Risk

K040893 is an FDA 510(k) clearance for the EASY CORE BIOPSY SYSTEM. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on May 6, 2004 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K040893

510(k) Number K040893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2004
Decision Date May 06, 2004
Days to Decision 30 days
Submission Type Special
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
101d faster than avg
Panel avg: 131d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 84
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K040893.
SONOTIP II ULTRASOUND NEEDLE SYSTEM
K051247 · Medi-Globe Corp. · Jun 2005
SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
K050503 · Olympus Medical Systems Corporation · May 2005
EASY CORE BIOPSY SYSTEM II
K050120 · Boston Scientific Corp · Feb 2005
MODIFICATION TO TEMNO BIOPSY NEEDLES
K024120 · Allegiance Healthcare Corp. · Jan 2003
DISPOSABLE ASPIRATION NEEDLE NA-200H
K023272 · The Olympus Optical Co. · Dec 2002
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
K012864 · Boston Scientific Corp · Oct 2001