Cleared Traditional

Codman Certas Plus Electronic Tool Kit

K181902 · Integra Lifesciences Corp. · Neurology
Oct 2018
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K181902 is an FDA 510(k) clearance for the Codman Certas Plus Electronic Tool Kit, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Integra Lifesciences Corp. (Mansfield, US). The FDA issued a Cleared decision on October 25, 2018, 101 days after receiving the submission on July 16, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number K181902 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2018
Decision Date October 25, 2018
Days to Decision 101 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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