Cleared Special

K130763 - BEACON TISSUE MARKER (FDA 510(k) Clearance)

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

K130763 · Scion Medical Technologies, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
49d
Days
Class 2
Risk

K130763 is an FDA 510(k) clearance for the BEACON TISSUE MARKER. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Scion Medical Technologies, LLC (Sauk Centre, US). The FDA issued a Cleared decision on May 8, 2013 after a review of 49 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Scion Medical Technologies, LLC devices

Submission Details

510(k) Number K130763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2013
Decision Date May 08, 2013
Days to Decision 49 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
65d faster than avg
Panel avg: 114d · This submission: 49d
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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