Cleared Traditional

K120559 - AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM

K120559 is an FDA 510(k) clearance for AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT..., 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 90-day FDA review.

K120559 · Aesculap, Inc. · Neurology device
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May 2012
Decision
90d
Days
Class 2
Risk

K120559 is an FDA 510(k) clearance for the AESCULAP-MEITHKE PROSA ADJUSTABLE 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 May 24, 2012 after a review of 90 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 Aesculap, Inc. devices

FDA 510(k) Submission Details - K120559

510(k) Number K120559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2012
Decision Date May 24, 2012
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 207
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K120559.
INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS
K140722 · Integra LifeSciences Corporation · Jan 2015
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K123524 · Medtronic Neurosurgery · Feb 2013
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
K122118 · Codman & Shurtleff, Inc. · Aug 2012
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
K113526 · Medos International SARL · Feb 2012
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
K110560 · Medtronic Neurosurgery · Nov 2011
AESCULAP- MEITHKE SHUNT SYSTEM
K110206 · Aesculap, Inc. · Oct 2011