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Nobles-Lai Video Imaging System

by Visioneering, Inc.

510(k) K940273

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 NumberK940273 Date22 May 1995ClearedStatusActive

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  • Withdrawn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.

The Nobles-Lai Video Imaging System is an endoscope, neurological, as defined in the device data. It is a video imaging system intended for neurological applications.

The system received FDA 510(k) clearance under K940273 on May 22, 1995, with a traditional clearance type and product code GWG. It is classified as a Class II device under regulation 882.1480, with neurology as the medical specialty and review panel. The device was submitted by Visioneering, Inc., and is not a third-party reviewed submission.

Questions

AI-generated answers, 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.

  • What is the Nobles-Lai Video Imaging System used for?

    The Nobles-Lai Video Imaging System is a video imaging system intended for neurological applications, as defined in its device classification as an endoscope, neurological, under regulation 882.1480.

  • How was the Nobles-Lai Video Imaging System cleared for market?

    The device received FDA 510(k) clearance under submission K940273 on May 22, 1995, with a traditional clearance type and was found substantially equivalent to a predicate device.

  • What regulatory class and product code apply to the Nobles-Lai Video Imaging System?

    It is classified as a Class II medical device with product code GWG under regulation 882.1480, which covers neurological endoscopes, as confirmed in the device data.