Cleared Traditional

K031049 - GUGLIELMI DETACHABLE COIL (GDC)

K031049 is an FDA 510(k) clearance for GUGLIELMI DETACHABLE COIL (GDC), manufactured by Boston Scientific, Target. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K031049 · Boston Scientific, Target · Neurology device
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Aug 2003
Decision
121d
Days
Class 2
Risk

K031049 is an FDA 510(k) clearance for the GUGLIELMI DETACHABLE COIL (GDC). Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Boston Scientific, Target (Fremont, US). The FDA issued a Cleared decision on August 1, 2003 after a review of 121 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 Boston Scientific, Target devices

FDA 510(k) Submission Details - K031049

510(k) Number K031049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2003
Decision Date August 01, 2003
Days to Decision 121 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
27d faster than avg
Panel avg: 148d · This submission: 121d
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 155
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K031049.
CONTOUR SE MICROSPHERES (SYRINGE)
K032707 · Boston Scientific Corp · Sep 2003
MODIFICATION TO CONTOUR SE MICROSPHERES
K032542 · Boston Scientific Corp · Sep 2003
SAPPHIRE DETACHABLE FIBER COILS
K031852 · Micro Therapeutics, Inc. · Aug 2003
SAPPHIRE DETACHABLE COIL SYSTEM
K030392 · Micro Therapeutics, Inc. · Jul 2003
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