Cleared Special

K062599 - MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS

K062599 is an FDA 510(k) clearance for MONITORR ICP EXTERNAL DRAINAGE AND MONI..., manufactured by Integra LifeSciences Corporation. The device is a Class 2 Neurology device with product code JXG cleared through the Special 510(k) pathway after a 26-day FDA review.

K062599 · Integra LifeSciences Corporation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
26d
Days
Class 2
Risk

K062599 is an FDA 510(k) clearance for the MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Plainsboro, US). The FDA issued a Cleared decision on September 27, 2006 after a review of 26 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 - K062599

510(k) Number K062599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2006
Decision Date September 27, 2006
Days to Decision 26 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
123d faster than avg
Panel avg: 149d · This submission: 26d
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 259
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K062599.
AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T
K062009 · Aesculap, Inc. · Jan 2007
CODMAN VPV SYSTEM, MODEL 82-3192
K061876 · Codman & Shurtleff, Inc. · Oct 2006
CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738
K061568 · Codman & Shurtleff, Inc. · Sep 2006
MEDTRONIC PS MEDICAL STRATA TYPE VALUE
K060681 · Medtronic Neurosurgery · Sep 2006
CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
K053107 · Codman & Shurtleff, Inc. · Jan 2006
MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS
K053350 · Codman & Shurtleff, Inc. · Jan 2006
K062599 · MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
Download PDF FDA Summary Integra LifeSciences …