Cleared Special

K103359 - FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)

K103359 is an FDA 510(k) clearance for FINESSE ULTRA BREAST BIOPSY SYSTEM DRIV..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Special 510(k) pathway after a 41-day FDA review.

K103359 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
41d
Days
Class 2
Risk

K103359 is an FDA 510(k) clearance for the FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK). Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on December 27, 2010 after a review of 41 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 - K103359

510(k) Number K103359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2010
Decision Date December 27, 2010
Days to Decision 41 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
90d faster than avg
Panel avg: 131d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
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 - KNW Instrument, Biopsy

All 362
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K103359.
ENCOR ENSPIRE BREAST BIOPSY SYSTEM
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MEDAX UNIPERSONALE SRL
K092338 · Medax Unipersonale Srl · May 2011
BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
K101832 · Medical Device Technologies, Inc. · Aug 2010
MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING
K093899 · Ethicon Endo-Surgery, LLC · Apr 2010
ENCOR BREAST BIOPSY SYSTEM
K093512 · Senorx, Inc. · Nov 2009
K103359 · FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)
Download PDF FDA Summary C.R. Bard, Inc.