Cleared Traditional

K143111 - Codman Certas Plus Programmable Valve

Also marketed or referenced as:
Codman Certas Toll Kit

K143111 is the FDA 510(k) clearance for Codman Certas Plus Programmable Valve by Medos International SARL. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K143111 · Medos International SARL · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
113d
Days
Class 2
Risk

K143111 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 February 19, 2015 after a review of 113 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 Medos International SARL devices

Submission Details

510(k) Number K143111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2014
Decision Date February 19, 2015
Days to Decision 113 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
35d faster than avg
Panel avg: 148d · This submission: 113d
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 Consultant

Codman & Shurtleff, Inc.
Michelle Godin

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JXG Shunt, Central Nervous System And Components

All 98
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K143111.
Codman EDS3 CSF External Drainage System
K162437 · Codman & Shurtleff, Inc. · Oct 2016
Codman Certas Plus Programmable Valve
K152152 · Medos International SARL · Oct 2015
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
K141687 · Aesculap, Inc. · Apr 2015
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
K122118 · Codman & Shurtleff, Inc. · Aug 2012
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
K120559 · Aesculap, Inc. · May 2012
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
K113526 · Medos International SARL · Feb 2012