Cleared Traditional

K042231 - GELSPHERES MICROSPHERES AND BEAD BLOCK ...

K042231 is an FDA 510(k) clearance for GELSPHERES MICROSPHERES AND BEAD BLOCK ..., manufactured by Biocompatibles UK Limited. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K042231 · Biocompatibles UK Limited · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
87d
Days
Class 2
Risk

K042231 is an FDA 510(k) clearance for the GELSPHERES MICROSPHERES AND 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 November 12, 2004 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - the FDA neurology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biocompatibles UK Limited devices

FDA 510(k) Submission Details - K042231

510(k) Number K042231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2004
Decision Date November 12, 2004
Days to Decision 87 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 148d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K042231.
NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR
K051425 · Micro Therapeutics, Inc. · Jun 2005
NEXUS DETACHABLE COIL SYSTEM
K050543 · Micro Therapeutics, Inc. · Apr 2005
MATRIX STRETCH RESISTANT (SR) COILS
K050700 · Boston Scientific Corp · Apr 2005
GDC-10 360 DEGREE COIL SR
K042539 · Boston Scientific Corp · Oct 2004
SAPPHIRE NXT DETACHABLE COIL SYSTEM
K041649 · Micro Therapeutics, Inc. · Jul 2004
MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)
K041551 · MicroVention, Inc. · Jul 2004