Cleared Special

K070436 - BIOMARC GOLD TISSUE MARKER

K070436 is an FDA 510(k) clearance for BIOMARC GOLD TISSUE MARKER, manufactured by Carbon Medical Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Special 510(k) pathway after a 29-day FDA review.

K070436 · Carbon Medical Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Mar 2007
Decision
29d
Days
Class 2
Risk

K070436 is an FDA 510(k) clearance for the BIOMARC GOLD TISSUE MARKER. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Carbon Medical Technologies, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 16, 2007 after a review of 29 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 Carbon Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K070436

510(k) Number K070436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2007
Decision Date March 16, 2007
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
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 108
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K070436.
CYTOPHIL TISSUE MARKER
K072219 · Cytophil, Inc. · Jan 2008
SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM
K072913 · Suros Surgical Systems, Inc. A Hologic Company · Jan 2008
KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536
K072216 · Kapp Surgical Instrument, Inc. · Nov 2007
ULTRACLIP II WING AND ULTRACLIP II COIL
K063238 · Inrad · Jan 2007
TISSUE SITE MARKING SYSTEM
K062528 · Suros Surgical Systems, Inc. · Jan 2007
MODIFICATION TO BIOMARC TISSUE MARKER
K063193 · Carbon Medical Technologies, Inc. · Nov 2006