Cleared Abbreviated

K080875 - PIGALILEO 4TH GENERATION SYSTEM

K080875 is an FDA 510(k) clearance for PIGALILEO 4TH GENERATION SYSTEM, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Abbreviated 510(k) pathway after a 109-day FDA review.

K080875 · Smith & Nephew, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
109d
Days
Class 2
Risk

K080875 is an FDA 510(k) clearance for the PIGALILEO 4TH GENERATION SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on July 18, 2008 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K080875

510(k) Number K080875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2008
Decision Date July 18, 2008
Days to Decision 109 days
Submission Type Abbreviated
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
40d faster than avg
Panel avg: 149d · This submission: 109d
Pathway characteristics
Standards-based clearance path.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 426
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K080875.
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
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K080875 · PIGALILEO 4TH GENERATION SYSTEM
Download PDF FDA Summary Smith & Nephew, Inc.