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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 ?
510(k)
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.
FDA-Cleared Indications
- For use by clinicians during neurological examinations.
- For assessing sensory nerve function and response.
- For evaluating sensitivity to tactile or sharp stimulation as part of a neurological assessment.
Clinical Applications
- Bedside sensory examination of patients with possible neurological disorders.
- Assessment of peripheral sensory nerve response.
- Comparison of sensation between corresponding areas of the body.
- Documentation of sensory findings during a neurological examination.
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.
Practical Considerations
- Use should follow the manufacturer’s instructions and institutional examination protocols.
- The device is intended for clinician use and does not replace a complete neurological examination or confirm a diagnosis by itself.
- Avoid use on broken, infected, or significantly irritated skin unless specifically directed by the product labeling or clinical protocol.
- The available FDA record does not provide MRI-safety information; do not assume MRI compatibility without confirming the current labeling.
- The available record does not specify device dimensions, packaging, reusability, or a defined service life; verify these details with the manufacturer.
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.