Cleared Traditional

K002476 - LUMBOPERITONEAL SHUNT SYSTEM

K002476 is an FDA 510(k) clearance for LUMBOPERITONEAL SHUNT SYSTEM, manufactured by Phoenix Biomedical Corp.. 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.

K002476 · Phoenix Biomedical Corp. · Neurology device
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Nov 2000
Decision
90d
Days
Class 2
Risk

K002476 is an FDA 510(k) clearance for the LUMBOPERITONEAL SHUNT SYSTEM. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Phoenix Biomedical Corp. (Valley Forge, US). The FDA issued a Cleared decision on November 9, 2000 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.

FDA 510(k) Submission Details - K002476

510(k) Number K002476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2000
Decision Date November 09, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 149d · 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 250
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K002476.
MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855
K012052 · Medtronic PS Medical · Feb 2002
HAKIM PROGRAMMER AND TRANSMITTER
K003564 · Codman & Shurtleff, Inc. · Dec 2000
SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901
K002970 · Medical Designs, LLC · Dec 2000
SOPHY SU8 PRESSURE ADJUSTABLE VALVE
K992465 · Sophysa SA · Sep 2000
MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022
K991502 · Medtronic PS Medical · Sep 2000
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K992226 · Radionics, Inc. · Aug 2000
K002476 · LUMBOPERITONEAL SHUNT SYSTEM
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