Cleared Special

K123911 - SENOMARK ULTRA BREAST TISSUE MARKER

K123911 is an FDA 510(k) clearance for SENOMARK ULTRA BREAST TISSUE MARKER, manufactured by C.R. Bard, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Special 510(k) pathway after a 22-day FDA review.

K123911 · C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
22d
Days
Class 2
Risk

K123911 is an FDA 510(k) clearance for the SENOMARK ULTRA BREAST TISSUE MARKER. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on January 10, 2013 after a review of 22 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K123911

510(k) Number K123911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2012
Decision Date January 10, 2013
Days to Decision 22 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

NEU Device Classification - Class 2, Special Controls

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 72
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K123911.
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SECRMARK BIOPSY SITE MARKING SYSTEM
K102768 · Hologic, Inc. · Dec 2010
PRELOADED TISSUE MARKER DEVICE
K100994 · Carbon Medical Technologies, Inc. · Apr 2010
ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
K090547 · C.R. Bard, Inc. · Mar 2009