Cleared Traditional

K113202 - TISSUE MARKER

K113202 is the FDA 510(k) clearance for TISSUE MARKER by Focal Therapeutics. It is a Class 2 General & Plastic Surgery device (product code NEU) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K113202 · Focal Therapeutics · General & Plastic Surgery device
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Feb 2012
Decision
120d
Days
Class 2
Risk

K113202 is an FDA 510(k) clearance for the TISSUE MARKER. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Focal Therapeutics (Portola Valley, US). The FDA issued a Cleared decision on February 28, 2012 after a review of 120 days - within the typical 510(k) review window.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Focal Therapeutics devices

Submission Details

510(k) Number K113202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2011
Decision Date February 28, 2012
Days to Decision 120 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 115d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 56
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K113202.
BNX Fine Needle Aspiration System
K142198 · Covidien, LLC · Oct 2014
ECHO TIP ULTRA FIDUCIAL NEEDLE
K141356 · Wilson-Cook Medical, Inc. · Jun 2014
SENOMARK ULTRA BREAST TISSUE MARKER
K123911 · C.R. Bard, Inc. · Jan 2013
SECRMARK BIOPSY SITE MARKING SYSTEM
K102768 · Hologic, Inc. · Dec 2010
ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
K090547 · C.R. Bard, Inc. · Mar 2009
INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
K053518 · Medical Device Technologies, Inc. · Jan 2006