Cleared Special

K094018 - LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES

K094018 is an FDA 510(k) clearance for LC BEAD MICROSPHERES, manufactured by Biocompatibles UK Limited. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 108-day FDA review.

K094018 · Biocompatibles UK Limited · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
108d
Days
Class 2
Risk

K094018 is an FDA 510(k) clearance for the LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Biocompatibles UK Limited (South West Ranches, US). The FDA issued a Cleared decision on April 16, 2010 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - the FDA neurology 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.

FDA 510(k) Submission Details - K094018

510(k) Number K094018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2009
Decision Date April 16, 2010
Days to Decision 108 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 149d · This submission: 108d
Pathway characteristics
Modification to existing cleared device.

HCG Device Classification - Class 2, Special Controls

Product Code HCG Device, Neurovascular Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5950
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 Neurology devices follow this clearance model.

Regulatory Peers - HCG Device, Neurovascular Embolization

All 185
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K094018.
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MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
K093919 · MicroVention, Inc. · Jan 2010
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K093358 · MicroVention, Inc. · Jan 2010