Cleared Abbreviated

K181382 - GuardianTM Burr Hole Cover System (FDA 510(k) Clearance)

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K181382 · St Jude Medical · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
56d
Days
Class 2
Risk

K181382 is an FDA 510(k) clearance for the GuardianTM Burr Hole Cover System. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by St Jude Medical (Plano, US). The FDA issued a Cleared decision on July 20, 2018 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5250 - 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.

View all St Jude Medical devices

Submission Details

510(k) Number K181382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2018
Decision Date July 20, 2018
Days to Decision 56 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 148d · This submission: 56d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GXR Cover, Burr Hole
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5250
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.