Neurological Endoscope

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K970162 ↗

FDA Product Code

GWG

Device Class

Class II

Regulation

21 CFR Part 882.1480

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Richard Wolf Medical Instruments Corp. →

• What is the neurological endoscope used for?

  The neurological endoscope is intended for direct visualization, diagnosis, and therapeutic application during intracranial procedures, including cyst fenestration, shunt placement, intraventricular coagulation, and ventriculostomy, as stated in the device description.

• Is the neurological endoscope reusable or single-use?

  The device is reusable, as explicitly specified in the description under the intended use and device characteristics, meaning it is designed for multiple uses after proper reprocessing.

• How was the neurological endoscope cleared for market?

  The device received FDA 510(k) clearance under submission number K970162, indicating it was found substantially equivalent to a legally marketed predicate device, as reflected in the decision description and clearance type fields.

• What regulatory classification does the neurological endoscope have?

  The device is classified as a Class II medical device under regulation number 882.1480 with product code GWG, as defined in the specifications section, which determines its regulatory controls and requirements.

• Who manufactures the neurological endoscope and where are they located?

  The neurological endoscope is manufactured by Richard Wolf Medical Instruments Corp., located at 353 Corporate Woods Pkwy., Vernon Hills, IL 60061, USA, as provided in the address and contact details.