Cleared Special

K094018 - LC BEAD 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)
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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.

View all Biocompatibles UK Limited devices

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
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 148d · 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 156
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K094018.
TARGET DETACHABLE COIL
K102672 · Boston Scientific Corp · Oct 2010
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K093973 · Codman & Shurtleff, Inc. · May 2010
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
K100454 · MicroVention, Inc. · Apr 2010
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
K093142 · Boston Scientific Corp · Feb 2010
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
K093919 · MicroVention, Inc. · Jan 2010
MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V
K093358 · MicroVention, Inc. · Jan 2010