Cleared Traditional

K073095 - TUMARK PROFESSIONAL

Also marketed or referenced as:
MR- TUMARK PROFESSIONAL, MODEL 601560

K073095 is an FDA 510(k) clearance for TUMARK PROFESSIONAL, manufactured by Somatex Medical Technologies GmbH. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K073095 · Somatex Medical Technologies GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K073095

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
24d slower than avg
Panel avg: 115d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 65
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