Cleared Traditional

K962503 - GUGLIELMI DETACHABLE COIL

K962503 is the FDA 510(k) clearance for GUGLIELMI DETACHABLE COIL by Target Therapeutics. It is a Class 2 Neurology device (product code HCG) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K962503 · Target Therapeutics · Neurology device
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Sep 1996
Decision
85d
Days
Class 2
Risk

K962503 is an FDA 510(k) clearance for the GUGLIELMI DETACHABLE COIL. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Target Therapeutics (Freemont, US). The FDA issued a Cleared decision on September 20, 1996 after a review of 85 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 Target Therapeutics devices

Submission Details

510(k) Number K962503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1996
Decision Date September 20, 1996
Days to Decision 85 days
Submission Type Traditional
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
63d faster than avg
Panel avg: 148d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 126
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K962503.
TRUFILL PVA PARTICLES
K965174 · Cordis Neurovascular, Inc. · Mar 1997
CES VASCULAR OCCLUSION SYSTEM
K964367 · Cordis Neurovascular, Inc. · Jan 1997
GDC PATIENT RETURN ELECTTRODE MODEL 45021
K963307 · Target Therapeutics · Dec 1996
BERENSTEIN COIL
K961923 · Target Therapeutics · Aug 1996
GUGLIELMI DETACHABLE COIL
K960705 · Target Therapeutics · May 1996
DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)
K951256 · Target Therapeutics · Sep 1995