Cleared Traditional

K023089 - GELSPHERES EMBOLIC AGENT

K023089 is an FDA 510(k) clearance for GELSPHERES EMBOLIC AGENT, manufactured by Biocure, Inc.. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K023089 · Biocure, Inc. · Neurology device
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Dec 2002
Decision
90d
Days
Class 2
Risk

K023089 is an FDA 510(k) clearance for the GELSPHERES EMBOLIC AGENT. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Biocure, Inc. (South West Ranches, US). The FDA issued a Cleared decision on December 16, 2002 after a review of 90 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. 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biocure, Inc. devices

FDA 510(k) Submission Details - K023089

510(k) Number K023089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2002
Decision Date December 16, 2002
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 159
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K023089.
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K030963 · Cordis Neurovascular, Inc. · Jun 2003
MATRIX STRETCH RESISTANT DETACHABLE COIL
K031168 · Boston Scientific, Target · May 2003
GDC STRETCH RESISTANT DETACHABLE COIL
K030475 · Boston Scientific, Target · Mar 2003
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT
K022735 · MicroVention, Inc. · Sep 2002
CONTOUR SE MICROSPHERES
K022427 · Boston Scientific Corp · Aug 2002
MICROPLEX COIL SYSTEM (MCS)
K020434 · MicroVention, Inc. · Jul 2002