Cleared Traditional

K152152 - Codman Certas Plus Programmable Valve

K152152 is an FDA 510(k) clearance for Codman Certas Plus Programmable Valve, manufactured by Medos International SARL. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K152152 · Medos International SARL · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
85d
Days
Class 2
Risk

K152152 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 Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on October 27, 2015 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medos International SARL devices

FDA 510(k) Submission Details - K152152

510(k) Number K152152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2015
Decision Date October 27, 2015
Days to Decision 85 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
63d faster than avg
Panel avg: 148d · This submission: 85d
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 184
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K152152.
StrataMR Valves and Shunts
K152700 · Medtronic Neurosurgery · Apr 2016
Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
K153041 · Integra LifeSciences Corporation · Mar 2016
Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
K152897 · Integra LifeSciences Corporation · Mar 2016
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
K141687 · Aesculap, Inc. · Apr 2015
Codman Certas Plus Programmable Valve
K143111 · Medos International SARL · Feb 2015
INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS
K140722 · Integra LifeSciences Corporation · Jan 2015