Stereotaxic Guiding Surgical Devices, NaoTrac S— 510(k) K242575

Name: FDA 510(k) clearance K242575
Creator: U.S. Food and Drug Administration
Published: 2025-05-23

Substantially Equivalent

Brain Navi Biotechnology Co., Ltd.

FDA 510(k) clearance K242575 for Stereotaxic Guiding Surgical Devices, NaoTrac S, Substantially Equivalent on 2025-05-23. Applicant: Brain Navi Biotechnology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Brain Navi Biotechnology Co., Ltd.
Product code: Product code HAW
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2024-08-29
Decision date: 2025-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu County, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code HAW

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K253856 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)2026-09-10
K261932 — Leksell® Vantage Stereotactic System2026-08-05
K253663 — Zeta Navigation System2026-05-01
K253379 — Stealth AXiS Cranial clinical application2026-03-26
K231897 — NeuroAlign software2025-10-21

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.