Cleared Special

K002181 - GDC ULTRASOFT COIL

K002181 is an FDA 510(k) clearance for GDC ULTRASOFT COIL, manufactured by Boston Scientific, Target. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 23-day FDA review.

K002181 · Boston Scientific, Target · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
23d
Days
Class 2
Risk

K002181 is an FDA 510(k) clearance for the GDC ULTRASOFT COIL. 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 11, 2000 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific, Target devices

FDA 510(k) Submission Details - K002181

510(k) Number K002181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2000
Decision Date August 11, 2000
Days to Decision 23 days
Submission Type Special
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
125d faster than avg
Panel avg: 148d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 K002181.
MATRIX DETACHABLE COILS
K012985 · Boston Scientific, Target · Jan 2002
MICROPLEX COIL SYSTEM
K012145 · MicroVention, Inc. · Oct 2001
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
K000651 · Cook, Inc. · Nov 2000
GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4
K001083 · Boston Scientific, Target · May 2000
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