Cleared Traditional

K042753 - MAMMOTOME MR BIOPSY SYSTEM

K042753 is the FDA 510(k) clearance for MAMMOTOME MR BIOPSY SYSTEM by Ethicon Endo-Surgery, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K042753 · Ethicon Endo-Surgery, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
35d
Days
Class 2
Risk

K042753 is an FDA 510(k) clearance for the MAMMOTOME MR BIOPSY SYSTEM. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 8, 2004 after a review of 35 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 Ethicon Endo-Surgery, Inc. devices

Submission Details

510(k) Number K042753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2004
Decision Date November 08, 2004
Days to Decision 35 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
95d faster than avg
Panel avg: 130d · This submission: 35d
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 109
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K042753.
VACORA VACUUM ASSISTED BIOPSY SYSTEM
K082681 · C.R. Bard, Inc. · Oct 2008
VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138
K062832 · C.R. Bard, Inc. · Oct 2006
EASY CORE DETACHABLE BIOPSY SYSTEM
K051361 · Boston Scientific Corp · Jun 2005
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
MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
K030472 · Ethicon Endo-Surgery, Inc. · Oct 2003