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Stereotaxic Guiding Surgical Devices, NaoTrac S

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K242575

by Brain Navi Biotechnology Co., Ltd.

Identifiers

510(k) Number
K242575 FDA 510(k)
FDA Product Code
HAW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Stereotaxic Guiding Surgical Devices, NaoTrac S is a Stereotaxic Instrument designed for precise neurosurgical guidance. It provides real-time tracking and alignment for targeted brain procedures, enhancing accuracy in stereotactic interventions such as biopsies, electrode placements, or deep brain stimulation.

This device is intended for single-use in sterile operating room environments and is classified under FDA 510(k) clearance (K242575) and MDD compliance. It operates within Neurology applications, adhering to Neurological Stereotaxic Instrument standards, and is supplied as a Class II medical device. No MRI safety or reusable specifications are stated.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Stereotaxic Guiding Surgical Devices, NaoTrac S (K242575) — FDA 510(k ..., PDF Brain Navi Biotechnology Co., Ltd. ℅ Feng Principal Regulatory ..., Stereotaxic Guiding Surgical Devices, NaoTrac S… - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Brain Navi Biotechnology Co., Ltd.

Sources (2)

  • FDA 510(k) K242575 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026