Cleared Traditional

K123259 - MAMMOTOME REOLVE DUAL VACUUM ASSISTED B...

K123259 is the FDA 510(k) clearance for MAMMOTOME REOLVE DUAL VACUUM ASSISTED B... by Devicor Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K123259 · Devicor Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
28d
Days
Class 2
Risk

K123259 is an FDA 510(k) clearance for the MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Devicor Medical Products, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 15, 2012 after a review of 28 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 Devicor Medical Products, Inc. devices

Submission Details

510(k) Number K123259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2012
Decision Date November 15, 2012
Days to Decision 28 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 157
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K123259.
Sertera Biopsy Device
K150169 · Hologic, Inc. · Aug 2015
Imbibe Aspirating XIA Taps
K143546 · Stryker Corporation · Mar 2015
IVAS 8 GAUGE BONE BIOPSY KIT
K141673 · Stryker Corporation · Sep 2014
ENCOR ENSPIRE BREAST BIOPSY SYSTEM
K111100 · C.R. Bard, Inc. · Jun 2011
FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)
K103359 · C.R. Bard, Inc. · Dec 2010
BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
K101832 · Medical Device Technologies, Inc. · Aug 2010