Cleared Traditional

CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)

K172022 · Codman & Shurtleff, Inc. · Neurology
Oct 2017
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K172022 is an FDA 510(k) clearance for the CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled), a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on October 3, 2017, 90 days after receiving the submission on July 5, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number K172022 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2017
Decision Date October 03, 2017
Days to Decision 90 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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