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Navigus Passive Probe (BL), Model NP-2000

by Image-Guided Neurologics, Inc.

510(k) K040834

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 NumberK040834 Date3 Jun 2004ClearedStatusActive

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  • Withdrawn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
HAW
Device Class
Class II
Regulation
21 CFR Part 882.4560
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 Navigus Passive Probe (BL), Model NP-2000 is a component of the Navigus trajectory navigation system designed for stereotaxic guidance during surgical procedures. It provides passive tracking capability within an image-guided navigation environment to assist in precise instrument positioning relative to patient anatomy.

This device is intended for use as part of the Navigus family of trajectory navigation in conjunction with the Image-Guided System. It is provided sterile for single-use and is operated by surgeons in clinical or operating room settings. The device has received FDA 510(k) clearance.

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