Cleared Traditional

K033761 - GELSPHERES / BEADBLOCK COMPRESSIBLE MIC...

K033761 is an FDA 510(k) clearance for GELSPHERES / BEADBLOCK COMPRESSIBLE MIC..., 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 64-day FDA review.

K033761 · Biocompatibles UK Limited · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
64d
Days
Class 2
Risk

K033761 is an FDA 510(k) clearance for the GELSPHERES / BEADBLOCK 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 February 4, 2004 after a review of 64 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 - K033761

510(k) Number K033761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2003
Decision Date February 04, 2004
Days to Decision 64 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
84d faster than avg
Panel avg: 148d · This submission: 64d
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 K033761.
SAPPHIRE NXT DETACHABLE COIL SYSTEM
K041649 · Micro Therapeutics, Inc. · Jul 2004
MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)
K041551 · MicroVention, Inc. · Jul 2004
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
K040694 · Micro Therapeutics, Inc. · Mar 2004
SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
K033372 · Micro Therapeutics, Inc. · Jan 2004
HYDROCOIL EMBOLIC SYSTEM (HES)
K033836 · MicroVention, Inc. · Dec 2003
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K032590 · MicroVention, Inc. · Oct 2003