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Teca Neuropto With OS-5 Stimulator

by Teca, Inc.

510(k) K861069

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 NumberK861069 Date27 Jan 1987ClearedStatusActive

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  • Withdrawn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, 25 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 Teca Neuropto With Os-5 Stimulator is a Stimulator, Photic, Evoked Response device, classified as a class 2 device. It is used in the field of Neurology. The device is substantially equivalent to other devices on the market.

The device is supplied with a product code of GWE and is regulated under regulation number 882.1890. It has been cleared by the FDA with a 510(k) number of K861069, with a decision date of 1987-01-27. The device is a traditional clearance type and was not reviewed by a third party.

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Questions

AI-generated answers, 25 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 Teca Neuropto With Os-5 Stimulator used for?

    The Teca Neuropto With Os-5 Stimulator is used in the field of Neurology as a photic evoked response device.

  • What is the regulatory classification of the device?

    The device is classified as a class 2 device and is regulated under regulation number 882.1890.

  • Is the device substantially equivalent to other devices on the market?

    Yes, the Teca Neuropto With Os-5 Stimulator is substantially equivalent to other devices on the market, as indicated by its FDA 510(k) clearance.

  • What is the product code of the device?

    The product code of the Teca Neuropto With Os-5 Stimulator is GWE.