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neurotips tm
Ulster Scientific
Summary: Neurotips tm is a clinician-facing device manufactured by Ulster Scientific, primarily used for neurological assessments. It is FDA 510k cleared with linked evidence from 9 studies, though specific outcomes and safety data are not detailed in the provided studies.
FDA Clearance Information
Pathway
510K
Number
K871571 ↗
Decision Date
June 18, 1987
Product Code
GXB
Device Class
Class 1
Evidence
0 studies
The neurotips tm device was cleared through the FDA 510k pathway on June 18, 1987. It is manufactured by Ulster Scientific and classified as a Class 1 device under product code GXB.
What It Is
Neurotips tm is a medical device designed for neurological examinations, facilitating assessments of sensory nerve function. It is intended for use by clinicians in evaluating nerve response and sensitivity.
Clinical Applications
Neurotips tm is commonly used in clinical settings for assessing patients with potential neurological disorders. It aids in diagnosing conditions by evaluating sensory nerve function and response.
Evidence Summary
The available literature includes 9 studies, though specific study types and outcomes are not detailed. The studies span various years, but the exact date range is not specified.
Reported Outcomes
Published studies report limited specific findings regarding the efficacy of neurotips tm. The evidence provided does not detail particular outcomes related to the device's clinical use.
Safety Profile
Reported complications include limited safety data as the provided studies do not specify adverse events or complications associated with neurotips tm.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to neurotips tm. Further research is needed to establish comprehensive efficacy and safety profiles, as well as to explore potential clinical applications.
Frequently Asked Questions
What are the clinical indications for neurotips tm?
Clinical indications are detailed in the FDA documentation, primarily for neurological assessments.
What outcomes have been reported in clinical studies?
Specific findings from the evidence are not detailed in the provided studies.
What complications have been reported?
Safety data from the evidence is limited, with no specific complications reported.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.