Cleared Traditional

K112411 - MAMMOTOME ELITE BIOPSY SYSTEM

K112411 is an FDA 510(k) clearance for MAMMOTOME ELITE BIOPSY SYSTEM, manufactured by Devicor Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K112411 · Devicor Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
211d
Days
Class 2
Risk

K112411 is an FDA 510(k) clearance for the MAMMOTOME ELITE BIOPSY 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 March 20, 2012 after a review of 211 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Devicor Medical Products, Inc. devices

FDA 510(k) Submission Details - K112411

510(k) Number K112411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2011
Decision Date March 20, 2012
Days to Decision 211 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
80d slower than avg
Panel avg: 131d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 290
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