Cleared Special

K031303 - AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)

K031303 is an FDA 510(k) clearance for AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY A..., manufactured by Aesculap, Inc.. The device is a Class 2 Neurology device with product code JXG cleared through the Special 510(k) pathway after a 41-day FDA review.

K031303 · Aesculap, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
41d
Days
Class 2
Risk

K031303 is an FDA 510(k) clearance for the AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV). 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 June 4, 2003 after a review of 41 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.

FDA 510(k) Submission Details - K031303

510(k) Number K031303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2003
Decision Date June 04, 2003
Days to Decision 41 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
108d faster than avg
Panel avg: 149d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

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 258
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K031303.
ACURA ELITE GRAVITY COMPENSATING RESERVOIR
K030468 · Phoenix Biomedical Corp. · Oct 2003
CSF400 AND CSF600
K030081 · Inmed Ltda. · Oct 2003
EXTERNAL DRAINAGE SET
K032817 · Integra Neurosciences Implants S.A. · Oct 2003
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
K030698 · Aesculap, Inc. · Mar 2003
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
K030289 · Integra Lifesciences Corp. · Feb 2003
ACCURA ELITE SHUNT SYSTEM
K024040 · Phoenix Biomedical Corp. · Jan 2003
K031303 · AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
Download PDF FDA Summary Aesculap, Inc.