Cleared Traditional

Stereotaxic Guiding Surgical Devices, NaoTrac S

K242575 · Brain Navi Biotechnology Co., Ltd. · Neurology

May 2025

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K242575 is an FDA 510(k) clearance for the Stereotaxic Guiding Surgical Devices, NaoTrac S, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Brain Navi Biotechnology Co., Ltd. (Hsinchu County, TW). The FDA issued a Cleared decision on May 23, 2025, 267 days after receiving the submission on August 29, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K242575 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2024
Decision Date	May 23, 2025
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF