Cleared Traditional

K112156 - CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM

K112156 is the FDA 510(k) clearance for CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM by Medos International SARL. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K112156 · Medos International SARL · Neurology device
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Optimized for regulatory review, auditing and printing
Oct 2011
Decision
82d
Days
Class 2
Risk

K112156 is an FDA 510(k) clearance for the CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Medos International SARL (Raynham, US). The FDA issued a Cleared decision on October 17, 2011 after a review of 82 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

Submission Details

510(k) Number K112156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2011
Decision Date October 17, 2011
Days to Decision 82 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
66d faster than avg
Panel avg: 148d · This submission: 82d
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 117
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K112156.
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
K120559 · Aesculap, Inc. · May 2012
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
K113526 · Medos International SARL · Feb 2012
AESCULAP- MEITHKE SHUNT SYSTEM
K110206 · Aesculap, Inc. · Oct 2011
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
K101381 · Integra LifeSciences Corporation · Jul 2011
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
K110751 · Codman & Shurtleff, Inc. · May 2011
HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS
K102961 · Codman & Shurtleff, Inc. · Feb 2011