Cleared Traditional

K073095 - TUMARK PROFESSIONAL, MODEL 271560 (FDA 510(k) Clearance)

Also includes:
MR- TUMARK PROFESSIONAL, MODEL 601560

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

K073095 · Somatex Medical Technologies GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Mar 2008
Decision
139d
Days
Class 2
Risk

K073095 is an FDA 510(k) clearance for the TUMARK PROFESSIONAL, MODEL 271560. 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 March 19, 2008 after a review of 139 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 K073095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2007
Decision Date March 19, 2008
Days to Decision 139 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: 114d · This submission: 139d
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 109
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