Cleared Special

K021494 - GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4

K021494 is an FDA 510(k) clearance for GDC POWER SUPPLY, 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 28-day FDA review.

K021494 · Boston Scientific, Target · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
28d
Days
Class 2
Risk

K021494 is an FDA 510(k) clearance for the GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4. 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 June 6, 2002 after a review of 28 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.

FDA 510(k) Submission Details - K021494

510(k) Number K021494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2002
Decision Date June 06, 2002
Days to Decision 28 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
121d faster than avg
Panel avg: 149d · This submission: 28d
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 185
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K021494.
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K021494 · GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4
Download PDF FDA Summary Boston Scientific, Ta…