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K Number
K002330

Validate with FDA (Live)

Device Name
NAVIGUS PEEL AWAY INTRODUCER
Manufacturer
IMAGE-GUIDED NEUROLOGICS, INC.
Date Cleared
2000-10-18

(78 days)

Product Code
GWG
Regulation Number
882.1480
Type
Traditional
Panel
Neurology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 882.1480 Neurological endoscope.

(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).