Cleared Special

K024040 - ACCURA ELITE SHUNT SYSTEM

K024040 is an FDA 510(k) clearance for ACCURA ELITE SHUNT SYSTEM, manufactured by Phoenix Biomedical Corp.. The device is a Class 2 Neurology device with product code JXG cleared through the Special 510(k) pathway after a 52-day FDA review.

K024040 · Phoenix Biomedical Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
52d
Days
Class 2
Risk

K024040 is an FDA 510(k) clearance for the ACCURA ELITE SHUNT SYSTEM. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Phoenix Biomedical Corp. (Norristown, US). The FDA issued a Cleared decision on January 27, 2003 after a review of 52 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 - K024040

510(k) Number K024040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2002
Decision Date January 27, 2003
Days to Decision 52 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
97d faster than avg
Panel avg: 149d · This submission: 52d
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 250
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K024040.
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
K031303 · Aesculap, Inc. · Jun 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
PHOENIX UNIVERSAL SHUNT SYSTEM
K024101 · Phoenix Biomedical Corp. · Jan 2003
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K022554 · Integra Neurosciences · Aug 2002
PERF (OMMAYA STYLE) RESERVOIRS
K021644 · Phoenix Biomedical Corp. · Aug 2002
K024040 · ACCURA ELITE SHUNT SYSTEM
Download PDF FDA Summary Phoenix Biomedical Co…