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Navigation Probes

by We Sense, Ltd.

510(k) K082404

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 NumberK082404 Date25 Feb 2009ClearedStatusActive

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  • Withdrawn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
GZL
Device Class
Class II
Regulation
21 CFR Part 882.1330
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Navigation Probes are a type of electrode, depth device used in neurology. They are substantially equivalent and have a device class of 2. The device is used as an electrode, depth device.

The Navigation Probes are supplied with various registration numbers and fei numbers. They have an FDA 510K authorization and are classified under regulation number 882.1330. The device is used in the field of neurology and has a product code of GZL.

Questions

AI-generated answers, 23 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 Navigation Probes device used for?

    The Navigation Probes are used as an electrode, depth device in the field of neurology.

  • What is the regulatory classification of the Navigation Probes?

    The Navigation Probes have a device class of 2 and are classified under regulation number 882.1330.

  • Are the Navigation Probes supplied with any specific registrations or numbers?

    Yes, the Navigation Probes are supplied with various registration numbers and FEI numbers, including those listed in the device's FDA 510K authorization.