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)
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.

View all Suros Surgical Systems, Inc. A Hologic Company devices

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
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 73
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K072913.
STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS
K081085 · Senorx, Inc. · Aug 2008
PROSTATE TISSUE MARKER
K081170 · Senorx, Inc. · May 2008
GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP
K080698 · Senorx, Inc. · Mar 2008
BIOMARC GOLD TISSUE MARKER
K070436 · Carbon Medical Technologies, Inc. · Mar 2007
MODIFICATION TO BIOMARC TISSUE MARKER
K063193 · Carbon Medical Technologies, Inc. · Nov 2006
INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
K053518 · Medical Device Technologies, Inc. · Jan 2006