Cleared Special

K072913 - SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM

K072913 is an FDA 510(k) clearance for SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM, manufactured by Suros Surgical Systems, Inc. A Hologic Company. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Special 510(k) pathway after a 84-day FDA review.

K072913 · Suros Surgical Systems, Inc. A Hologic Company · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
84d
Days
Class 2
Risk

K072913 is an FDA 510(k) clearance for the SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Suros Surgical Systems, Inc. A Hologic Company (Indianapolis, US). The FDA issued a Cleared decision on January 4, 2008 after a review of 84 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.

FDA 510(k) Submission Details - K072913

510(k) Number K072913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2007
Decision Date January 04, 2008
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 109
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K072913.
GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP
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TUMARK PROFESSIONAL, MODEL 271560
K073095 · Somatex Medical Technologies GmbH · Mar 2008
CYTOPHIL TISSUE MARKER
K072219 · Cytophil, Inc. · Jan 2008
KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536
K072216 · Kapp Surgical Instrument, Inc. · Nov 2007
BIOMARC GOLD TISSUE MARKER
K070436 · Carbon Medical Technologies, Inc. · Mar 2007
ULTRACLIP II WING AND ULTRACLIP II COIL
K063238 · Inrad · Jan 2007
K072913 · SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM
Download PDF FDA Summary Suros Surgical System…