Cleared Traditional

K093899 - MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR I...

K093899 is the FDA 510(k) clearance for MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR I... by Ethicon Endo-Surgery, LLC. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K093899 · Ethicon Endo-Surgery, LLC · Gastroenterology & Urology device
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Apr 2010
Decision
132d
Days
Class 2
Risk

K093899 is an FDA 510(k) clearance for the MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on April 29, 2010 after a review of 132 days - within the typical 510(k) review window.

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 Ethicon Endo-Surgery, LLC devices

Submission Details

510(k) Number K093899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2009
Decision Date April 29, 2010
Days to Decision 132 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
2d slower than avg
Panel avg: 130d · This submission: 132d
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 142
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K093899.
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VACORA VACUUM ASSISTED BIOPSY SYSTEM
K082681 · C.R. Bard, Inc. · Oct 2008
DELTACUT (APPARATUS AND CANNULA)
K063233 · PAJUNK GmbH Medizintechnologie · Apr 2007