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Disposable Neuroview Endoscope

by Neuro Navigational Corp.

510(k) K923479

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK923479 Date19 Feb 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GWG
Device Class
Class II
Regulation
21 CFR Part 882.1480
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An Endoscope, Neurological is a device intended for visual examination and treatment of the neurological system. This disposable endoscope is designed for single-use procedures in neurological applications.

It is supplied sterile for single-use and has been cleared under FDA 510(k) K923479 with product code GWG and regulation number 882.1480. The device is classified as Class II and was determined substantially equivalent to a predicate device following a traditional 510(k) review.

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