Cleared Abbreviated

GuardianTM Burr Hole Cover System

K181382 · St Jude Medical · Neurology
Jul 2018
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K181382 is an FDA 510(k) clearance for the GuardianTM Burr Hole Cover System, a Cover, Burr Hole (Class II — Special Controls, product code GXR), submitted by St Jude Medical (Plano, US). The FDA issued a Cleared decision on July 20, 2018, 56 days after receiving the submission on May 25, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5250.

Submission Details

510(k) Number K181382 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GXR — Cover, Burr Hole
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5250

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