Cleared Special

K013356 - WILSON-COOK ULTRASOUND BIOPSY NEEDLE

K013356 is an FDA 510(k) clearance for WILSON-COOK ULTRASOUND BIOPSY NEEDLE, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCG cleared through the Special 510(k) pathway after a 9-day FDA review.

K013356 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
9d
Days
Class 2
Risk

K013356 is an FDA 510(k) clearance for the WILSON-COOK ULTRASOUND BIOPSY NEEDLE. Classified as Biopsy Needle (product code FCG), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on October 19, 2001 after a review of 9 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.

FDA 510(k) Submission Details - K013356

510(k) Number K013356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2001
Decision Date October 19, 2001
Days to Decision 9 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
122d faster than avg
Panel avg: 131d · This submission: 9d
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 132
Devices cleared under the same product code (FCG) and FDA review panel - the closest regulatory comparables to K013356.
JAMSHIDI BIOPSY NEEDLE
K013070 · H.S. Hospital Services S.P.A. · Dec 2001
SECURCUT ASPIRATION BIOPSY NEEDLE
K013071 · H.S. Hospital Services S.P.A. · Dec 2001
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
K012864 · Boston Scientific Corp · Oct 2001
CHIBA NEEDLE
K012358 · Ispg, Inc. · Oct 2001
EASYBELL
K011075 · Biopsybell S.A.S. · Jun 2001
AUTOMATED CORE BIOPSY DEVICE
K011270 · Promex, Inc. · Jun 2001
K013356 · WILSON-COOK ULTRASOUND BIOPSY NEEDLE
Download PDF FDA Summary Wilson-Cook Medical, …