Cleared Traditional

K110206 - AESCULAP- MEITHKE SHUNT SYSTEM

K110206 is the FDA 510(k) clearance for AESCULAP- MEITHKE SHUNT SYSTEM by Aesculap, Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K110206 · Aesculap, Inc. · Neurology device
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Oct 2011
Decision
275d
Days
Class 2
Risk

K110206 is an FDA 510(k) clearance for the AESCULAP- MEITHKE SHUNT SYSTEM. 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 October 27, 2011 after a review of 275 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 K110206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2011
Decision Date October 27, 2011
Days to Decision 275 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
127d slower than avg
Panel avg: 148d · This submission: 275d
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 K110206.
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
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
K112156 · Medos International SARL · 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