Cleared Traditional

MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 (K080499) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080499 · The Magstim Company , Ltd. · Neurology device
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Dec 2008
Decision
287d
Days
Class 2
Risk

K080499 is an FDA 510(k) clearance for the MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by The Magstim Company , Ltd. (Carmarthenshire, GB). The FDA issued a Cleared decision on December 8, 2008 after a review of 287 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 The Magstim Company , Ltd. devices

Submission Details

510(k) Number K080499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2008
Decision Date December 08, 2008
Days to Decision 287 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 148d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 21
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K080499.
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