Cleared Traditional

K991139 - GUGLIELMI DETACHABLE (GDC)

K991139 is an FDA 510(k) clearance for GUGLIELMI DETACHABLE (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 261-day FDA review.

K991139 · Boston Scientific, Target · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
261d
Days
Class 2
Risk

K991139 is an FDA 510(k) clearance for the GUGLIELMI DETACHABLE (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 December 22, 1999 after a review of 261 days - an extended review 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: 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 - K991139

510(k) Number K991139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1999
Decision Date December 22, 1999
Days to Decision 261 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
113d slower than avg
Panel avg: 148d · This submission: 261d
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 K991139.
GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1
K993415 · Boston Scientific, Target · Jan 2000
GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC)
K993417 · Boston Scientific, Target · Jan 2000
FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL
K993418 · Boston Scientific, Target · Jan 2000
VASCULAR OCCLUSION SYSTEM
K983483 · Cordis Neurovascular, Inc. · Mar 1999
CES VASCULAR OCCLUSION SYSTEM
K972881 · Cordis Neurovascular, Inc. · Jun 1998
TRUFILL PVA PARTICLES
K965174 · Cordis Neurovascular, Inc. · Mar 1997