Cleared Traditional

TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 (K093064) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093064 · Somatex Medical Technologies GmbH · General & Plastic Surgery device
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Feb 2010
Decision
140d
Days
Class 2
Risk

K093064 is an FDA 510(k) clearance for the TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Somatex Medical Technologies GmbH (Cambridge, US). The FDA issued a Cleared decision on February 17, 2010 after a review of 140 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 Somatex Medical Technologies GmbH devices

Submission Details

510(k) Number K093064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2009
Decision Date February 17, 2010
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
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 48
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K093064.
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
8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535
K020276 · Ethicon Endo-Surgery, Inc. · Apr 2002
MICROMARK II TISSUE MARKER,MODEL C1535
K013413 · Ethicon Endo-Surgery, Inc. · Dec 2001