Cleared Traditional

K181902 - Codman Certas Plus Electronic Tool Kit

K181902 is the FDA 510(k) clearance for Codman Certas Plus Electronic Tool Kit by Integra Lifesciences Corp.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

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

K181902 is an FDA 510(k) clearance for the Codman Certas Plus Electronic Tool Kit. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (Mansfield, US). The FDA issued a Cleared decision on October 25, 2018 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Integra Lifesciences Corp. devices

Submission Details

510(k) Number K181902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 148d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - JXG Shunt, Central Nervous System And Components

All 156
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K181902.
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
K191684 · Integra LifeSciences Corporation · Oct 2019
Miethke Shunt System GAV 2.0 and SA 2.0 Valves
K190174 · Aesculap, Inc. · Jul 2019
CodMan Certas Plus Programmable Valve
K182265 · Integra Lifesciences Corp. · Nov 2018
StrataMR guider tool
K181622 · Medtronic Neurosurgery · Oct 2018
IRRAflow CNS System
K171880 · Irras, Inc. · Jul 2018
Smart External Drain (SED) System
K181301 · Aqueduct Critical Care, Inc. · Jun 2018