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U.S. Department of Health and Human Services

Product Classification

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Device endoscope, neurological
Regulation Description Neurological endoscope.
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGWG
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostics (DHT5A)
Submission Type 510(k)
Regulation Number 882.1480
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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