Cleared Traditional

K960705 - GUGLIELMI DETACHABLE COIL

K960705 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 90-day FDA review.

K960705 · Target Therapeutics · Neurology device
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May 1996
Decision
90d
Days
Class 2
Risk

K960705 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 May 21, 1996 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 Target Therapeutics devices

Submission Details

510(k) Number K960705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1996
Decision Date May 21, 1996
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 K960705.
GDC PATIENT RETURN ELECTTRODE MODEL 45021
K963307 · Target Therapeutics · Dec 1996
GUGLIELMI DETACHABLE COIL
K962503 · Target Therapeutics · Sep 1996
BERENSTEIN COIL
K961923 · Target Therapeutics · Aug 1996
DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)
K951256 · Target Therapeutics · Sep 1995
TRUEFILL PVA PARTICLES
K951314 · Cordis Neurovascular, Inc. · Aug 1995
HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
K911779 · Target Therapeutics · Nov 1991