Cleared Special

K153189 - Beacon Tissue Marker (SE)

K153189 is an FDA 510(k) clearance for Beacon Tissue Marker (SE), manufactured by Scion Medical Technologies, LLC. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Special 510(k) pathway after a 44-day FDA review.

K153189 · Scion Medical Technologies, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Dec 2015
Decision
44d
Days
Class 2
Risk

K153189 is an FDA 510(k) clearance for the Beacon Tissue Marker (SE). Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Scion Medical Technologies, LLC (Newtown Square, US). The FDA issued a Cleared decision on December 17, 2015 after a review of 44 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

FDA 510(k) Submission Details - K153189

510(k) Number K153189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2015
Decision Date December 17, 2015
Days to Decision 44 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
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Modification to existing cleared device.

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
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K153189.
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