Cleared Traditional

K182265 - CodMan Certas Plus Programmable Valve

K182265 is an FDA 510(k) clearance for CodMan Certas Plus Programmable Valve, manufactured by Integra Lifesciences Corp.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K182265 · Integra Lifesciences Corp. · Neurology device
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Nov 2018
Decision
91d
Days
Class 2
Risk

K182265 is an FDA 510(k) clearance for the CodMan Certas Plus Programmable Valve. 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 November 20, 2018 after a review of 91 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

FDA 510(k) Submission Details - K182265

510(k) Number K182265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2018
Decision Date November 20, 2018
Days to Decision 91 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
57d faster than avg
Panel avg: 148d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

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 220
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K182265.
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
K192289 · Irras USA, Ltd. · Nov 2019
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 Electronic Tool Kit
K181902 · Integra Lifesciences Corp. · Oct 2018
StrataMR guider tool
K181622 · Medtronic Neurosurgery · Oct 2018
IRRAflow CNS System
K171880 · Irras, Inc. · Jul 2018