Cleared Traditional

MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System

K191684 · Integra LifeSciences Corporation · Neurology
Oct 2019
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K191684 is an FDA 510(k) clearance for the MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on October 11, 2019, 109 days after receiving the submission on June 24, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number K191684 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2019
Decision Date October 11, 2019
Days to Decision 109 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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