Cleared Traditional

K062009 - AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE

K062009 is the FDA 510(k) clearance for AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE by Aesculap, Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K062009 · Aesculap, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Jan 2007
Decision
184d
Days
Class 2
Risk

K062009 is an FDA 510(k) clearance for the AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on January 17, 2007 after a review of 184 days - an extended review 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: 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 Aesculap, Inc. devices

Submission Details

510(k) Number K062009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2006
Decision Date January 17, 2007
Days to Decision 184 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
36d slower than avg
Panel avg: 148d · This submission: 184d
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 156
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K062009.
CODMAN HAKIM MICRO II VALVE
K091346 · Codman & Shurtleff, Inc. · Jun 2009
CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET
K090348 · Codman & Shurtleff, Inc. · Mar 2009
LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
K072929 · Integra LifeSciences Corporation · Dec 2007
CODMAN VPV SYSTEM, MODEL 82-3192
K061876 · Codman & Shurtleff, Inc. · Oct 2006
CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738
K061568 · Codman & Shurtleff, Inc. · Sep 2006
MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
K062599 · Integra LifeSciences Corporation · Sep 2006