Cleared Traditional

M. Blue Adjustable Shunt System

K192266 · Aesculap, Inc. · Neurology
Nov 2019
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K192266 is an FDA 510(k) clearance for the M. Blue Adjustable Shunt System, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on November 21, 2019, 92 days after receiving the submission on August 21, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number K192266 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2019
Decision Date November 21, 2019
Days to Decision 92 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code JXG — Shunt, Central Nervous System And Components
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5550

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