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510(k) Data Aggregation
K Number
K024040Device Name
ACCURA ELITE SHUNT SYSTEMManufacturer
Date Cleared
2003-01-27
(52 days)
Product Code
Regulation Number
882.5550Type
SpecialPanel
NeurologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
ACCURA ELITE SHUNT SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Accura Elite Shunt System is intended for use as the principle of a cerebrospinal fluid shunt assembly, used in the treatment of hydrocephalus.
Device Description
Not Found
AI/ML Overview
This document is an FDA 510(k) clearance letter for the Accura Elite Shunt System, a Central Nervous System Fluid Shunt and Components. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device has been found substantially equivalent to a legally marketed predicate device and can therefore be marketed.
Therefore, I cannot provide the requested information.
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