Cleared Special

K080698 - GEL MARK ULTRACOR BIOPSY SITE MARKER

K080698 is the FDA 510(k) clearance for GEL MARK ULTRACOR BIOPSY SITE MARKER by Senorx, Inc.. It is a Class 2 General & Plastic Surgery device (product code NEU) cleared through the Special 510(k) pathway after a 19-day FDA review.

K080698 · Senorx, Inc. · General & Plastic Surgery device
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Mar 2008
Decision
19d
Days
Class 2
Risk

K080698 is an FDA 510(k) clearance for the GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP. 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 March 31, 2008 after a review of 19 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 K080698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2008
Decision Date March 31, 2008
Days to Decision 19 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 115d · This submission: 19d
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 K080698.
SENOMARK ULTRA BREAST TISSUE MARKER
K123911 · C.R. Bard, Inc. · Jan 2013
SECRMARK BIOPSY SITE MARKING SYSTEM
K102768 · Hologic, Inc. · Dec 2010
ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
K090547 · C.R. Bard, Inc. · Mar 2009
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