Cleared Traditional

K110206 - AESCULAP- MEITHKE SHUNT SYSTEM

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

K110206 · Aesculap, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K110206

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.

JXG Device Classification - Class 2, Special Controls

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 214
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K110206.
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
K120559 · Aesculap, Inc. · May 2012
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
K113526 · Medos International SARL · Feb 2012
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
K110560 · Medtronic Neurosurgery · Nov 2011
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