Cleared Traditional

K973525 - MAURICE WORLDWIDE SHUNT SYSTEM

K973525 is an FDA 510(k) clearance for MAURICE WORLDWIDE SHUNT SYSTEM, manufactured by Integra Neurocare, LLC. 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.

K973525 · Integra Neurocare, LLC · Neurology device
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Dec 1997
Decision
90d
Days
Class 2
Risk

K973525 is an FDA 510(k) clearance for the MAURICE WORLDWIDE SHUNT SYSTEM. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra Neurocare, LLC (Pleasant Prairie, US). The FDA issued a Cleared decision on December 16, 1997 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 Integra Neurocare, LLC devices

FDA 510(k) Submission Details - K973525

510(k) Number K973525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1997
Decision Date December 16, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
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 177
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K973525.
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
K980778 · Johnson & Johnson Professionals, Inc. · Jul 1998
HAKIM PROGRAMMABLE VALVE SYSTEM
K974739 · Johnson & Johnson Professionals, Inc. · Jul 1998
CODMAN HAKIM MICRO PRECISION VALVE
K973774 · Johnson & Johnson Professionals, Inc. · Dec 1997
RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE
K971511 · Radionics, Inc. · Jul 1997
CODMAN LUMBAR DRAINAGE CATHETER KIT
K964923 · Johnson & Johnson Professionals, Inc. · Jun 1997
RADIONICS BURR HOLE VALVE
K970578 · Radionics, Inc. · Jun 1997