Cleared Traditional

K050739 - CODMAN VPV SYSTEM

K050739 is the FDA 510(k) clearance for CODMAN VPV SYSTEM by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K050739 · Codman & Shurtleff, Inc. · Neurology device
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Jul 2005
Decision
119d
Days
Class 2
Risk

K050739 is an FDA 510(k) clearance for the CODMAN VPV SYSTEM, MODEL 82-3192. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on July 18, 2005 after a review of 119 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 Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K050739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2005
Decision Date July 18, 2005
Days to Decision 119 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
29d faster than avg
Panel avg: 148d · This submission: 119d
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 K050739.
MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
K062599 · Integra LifeSciences Corporation · Sep 2006
CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
K053107 · Codman & Shurtleff, Inc. · Jan 2006
MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS
K053350 · Codman & Shurtleff, Inc. · Jan 2006
ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
K042825 · Integra LifeSciences Corporation · Dec 2004
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
K041296 · Codman & Shurtleff, Inc. · Jun 2004
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
K031303 · Aesculap, Inc. · Jun 2003