Cleared Special

K131654 - STARCHMARK BREAST TISSUE MARKER

Also marketed or referenced as:
STARCHMARK ULTRACOR BREAST TISSUE MARKER

K131654 is an FDA 510(k) clearance for STARCHMARK BREAST TISSUE MARKER, manufactured by Senorx, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Special 510(k) pathway after a 21-day FDA review.

K131654 · Senorx, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
21d
Days
Class 2
Risk

K131654 is an FDA 510(k) clearance for the STARCHMARK BREAST TISSUE MARKER. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Senorx, Inc. (Tempe, US). The FDA issued a Cleared decision on June 27, 2013 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

FDA 510(k) Submission Details - K131654

510(k) Number K131654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2013
Decision Date June 27, 2013
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
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 92
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K131654.
GENERAL AND PLASTIC SURGERY
K140835 · Scion Medical Technologies, LLC · May 2014
BIOMARC FIDUCIAL MARKER
K132708 · Carbon Medical Technologies, Inc. · Dec 2013
CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM
K132463 · Cianna Medical, Inc. · Dec 2013
BEACON TISSUE MARKER
K130763 · Scion Medical Technologies, LLC · May 2013
BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER
K130537 · Biopsy Sciences, LLC · Mar 2013
MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML
K121964 · Augmenix, Inc. · Jan 2013