Cleared Special

K111692 - TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K111692 · Somatex Medical Technologies GmbH · General & Plastic Surgery device
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Nov 2011
Decision
145d
Days
Class 2
Risk

K111692 is an FDA 510(k) clearance for the TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Somatex Medical Technologies GmbH (Wurmlingen, DE). The FDA issued a Cleared decision on November 8, 2011 after a review of 145 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Somatex Medical Technologies GmbH devices

Submission Details

510(k) Number K111692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2011
Decision Date November 08, 2011
Days to Decision 145 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 114d · This submission: 145d
Pathway characteristics
Modification to existing cleared device.

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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