Cleared Special

K103003 - AESCULAP- MEITHKE PROGAV PROGRAMMABLE S...

K103003 is the FDA 510(k) clearance for AESCULAP- MEITHKE PROGAV PROGRAMMABLE S... by Aesculap, Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Special 510(k) pathway after a 28-day FDA review.

K103003 · Aesculap, Inc. · Neurology device
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Nov 2010
Decision
28d
Days
Class 2
Risk

K103003 is an FDA 510(k) clearance for the AESCULAP- MEITHKE PROGAV PROGRAMMABLE 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 November 9, 2010 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aesculap, Inc. devices

Submission Details

510(k) Number K103003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2010
Decision Date November 09, 2010
Days to Decision 28 days
Submission Type Special
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
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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
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K090348 · Codman & Shurtleff, Inc. · Mar 2009