Cleared Special

K040842 - SENORX BIOPSY DEVICE II

K040842 is the FDA 510(k) clearance for SENORX BIOPSY DEVICE II by Senorx, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Special 510(k) pathway after a 29-day FDA review.

K040842 · Senorx, Inc. · Gastroenterology & Urology device
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Apr 2004
Decision
29d
Days
Class 2
Risk

K040842 is an FDA 510(k) clearance for the SENORX BIOPSY DEVICE II. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Senorx, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on April 30, 2004 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Senorx, Inc. devices

Submission Details

510(k) Number K040842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2004
Decision Date April 30, 2004
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 161
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K040842.
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
V-CORE FULL CORE BREAST BIOPSY INSTRUMENT
K042464 · Medical Device Technologies, Inc. · Sep 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
MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
K030472 · Ethicon Endo-Surgery, Inc. · Oct 2003