Cleared Special

K030698 - AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV

K030698 is an FDA 510(k) clearance for AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV, 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 14-day FDA review.

K030698 · Aesculap, Inc. · Neurology device
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Mar 2003
Decision
14d
Days
Class 2
Risk

K030698 is an FDA 510(k) clearance for the AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV. 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 March 20, 2003 after a review of 14 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

FDA 510(k) Submission Details - K030698

510(k) Number K030698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2003
Decision Date March 20, 2003
Days to Decision 14 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
134d faster than avg
Panel avg: 148d · This submission: 14d
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 220
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K030698.
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
K041296 · Codman & Shurtleff, Inc. · Jun 2004
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
K033850 · Medtronic Neurosurgery · Jan 2004
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K031303 · Aesculap, Inc. · Jun 2003
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
K030289 · Integra Lifesciences Corp. · Feb 2003
CODMAN BACTISEAL EVD CATHETER SET
K021653 · Codman & Shurtleff, Inc. · Jul 2002
CODMAN HAKIM SHUNT SYSTEMS
K020667 · Codman & Shurtleff, Inc. · Mar 2002