Cleared Traditional

K972994 - EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS

K972994 is an FDA 510(k) clearance for EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS, 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 83-day FDA review.

K972994 · Integra Neurocare, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
83d
Days
Class 2
Risk

K972994 is an FDA 510(k) clearance for the EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS. 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 November 3, 1997 after a review of 83 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Integra Neurocare, LLC devices

FDA 510(k) Submission Details - K972994

510(k) Number K972994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1997
Decision Date November 03, 1997
Days to Decision 83 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 148d · This submission: 83d
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 K972994.
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