Cleared Traditional

K152586 - Beacon Fine Needle Fiducial System

K152586 is an FDA 510(k) clearance for Beacon Fine Needle Fiducial System, manufactured by Covidien, LLC. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K152586 · Covidien, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
111d
Days
Class 2
Risk

K152586 is an FDA 510(k) clearance for the Beacon Fine Needle Fiducial System. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Covidien, LLC (Mansfield, US). The FDA issued a Cleared decision on December 30, 2015 after a review of 111 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.

FDA 510(k) Submission Details - K152586

510(k) Number K152586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2015
Decision Date December 30, 2015
Days to Decision 111 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 115d · This submission: 111d
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 109
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K152586.
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Beacon Tissue Marker (SE)
K153189 · Scion Medical Technologies, LLC · Dec 2015
BioZorb LP Marker
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TraceIT Tissue Marker - 3mL
K151998 · Augmenix, Inc. · Aug 2015
K152586 · Beacon Fine Needle Fiducial System
Download PDF FDA Summary Covidien, LLC