Cleared Traditional

K042464 - V-CORE FULL CORE BREAST BIOPSY INSTRUMENT

K042464 is the FDA 510(k) clearance for V-CORE FULL CORE BREAST BIOPSY INSTRUMENT by Medical Device Technologies, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K042464 · Medical Device Technologies, Inc. · Gastroenterology & Urology device
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Sep 2004
Decision
17d
Days
Class 2
Risk

K042464 is an FDA 510(k) clearance for the V-CORE FULL CORE BREAST BIOPSY INSTRUMENT. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Medical Device Technologies, Inc. (Wheeling, US). The FDA issued a Cleared decision on September 30, 2004 after a review of 17 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 Medical Device Technologies, Inc. devices

Submission Details

510(k) Number K042464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2004
Decision Date September 30, 2004
Days to Decision 17 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
113d faster than avg
Panel avg: 130d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 173
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K042464.
ENCOR 7 GAUGE
K051158 · Senorx, Inc. · May 2005
INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
K043523 · Medical Device Technologies, Inc. · Feb 2005
MAMMOTOME MR BIOPSY SYSTEM
K042753 · Ethicon Endo-Surgery, Inc. · Nov 2004
SENORX BIOPSY DEVICE II
K040842 · Senorx, Inc. · Apr 2004
MAMMOTOME EX HAND HELD SYSTEM
K033700 · Ethicon Endo-Surgery, Inc. · Feb 2004
STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS
K032943 · Stryker Corp. · Dec 2003