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Model S10VS Visual Stimulator

by Grass Instrument Co.

510(k) K812061

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 NumberK812061 Date20 Aug 1981ClearedStatusActive

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  • Withdrawn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
GWE
Device Class
Class II
Regulation
21 CFR Part 882.1890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Model S10VS Visual Stimulator is a photic stimulator designed to evoke visual responses. Classified as a Stimulator, Photic, Evoked Response, it is intended for use in neurological assessments to elicit and measure visual evoked potentials (VEPs). This device delivers controlled light stimuli to evaluate the functional integrity of the visual pathway.

The Model S10VS is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K812061) with a decision classification of Substantially Equivalent. It is intended for use in clinical settings, such as neurology departments, and adheres to regulatory standards outlined in 21 CFR 882.1890. No specific sterility or MRI safety information is provided in the available data.

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