Cleared Special

K040706 - GEL MARK IV

K040706 is the FDA 510(k) clearance for GEL MARK IV by Senorx, Inc.. It is a Class 2 General & Plastic Surgery device (product code NEU) cleared through the Special 510(k) pathway after a 21-day FDA review.

K040706 · Senorx, Inc. · General & Plastic Surgery device
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Apr 2004
Decision
21d
Days
Class 2
Risk

K040706 is an FDA 510(k) clearance for the GEL MARK IV. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Senorx, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on April 8, 2004 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery 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 K040706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2004
Decision Date April 08, 2004
Days to Decision 21 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NEU Marker, Radiographic, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NEU Marker, Radiographic, Implantable

All 58
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K040706.
INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
K053518 · Medical Device Technologies, Inc. · Jan 2006
INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
K051421 · Medical Device Technologies, Inc. · Aug 2005
MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
K040990 · Walter Lorenz Surgical, Inc. · May 2004
CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376
K033447 · Mri Devices Corp. · Jan 2004
8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535
K020276 · Ethicon Endo-Surgery, Inc. · Apr 2002
SELF-DRILLING RADIOGRAPHIC MARKER
K014148 · Walter Lorenz Surgical, Inc. · Jan 2002