Cleared Traditional

K091163 - PG471W

K091163 is the FDA 510(k) clearance for PG471W by Fiab Spa. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K091163 · Fiab Spa · Neurology device
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Jul 2009
Decision
91d
Days
Class 2
Risk

K091163 is an FDA 510(k) clearance for the PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISP.... Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Fiab Spa (Firenze, IT). The FDA issued a Cleared decision on July 22, 2009 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Fiab Spa devices

Submission Details

510(k) Number K091163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2009
Decision Date July 22, 2009
Days to Decision 91 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
57d faster than avg
Panel avg: 148d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 142
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