FDA.reportPublic FDA data

510(k) K242575

Device
Stereotaxic Guiding Surgical Devices, NaoTrac S
Applicant
Brain Navi Biotechnology Co., Ltd.
510(k) number
K242575
Product code
HAW
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-23
Date received
2024-08-29
Regulation
882.4560
Classification name
Neurological Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
I-Ju Lu
Address
# 66-1, Shengyi 5th Rd., Zhubei City Hsinchu County TW 302041 302041

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HAW#

510(k), Device, Applicant table
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K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB2026-08-05
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K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.2026-03-26
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K241327Navient Image Guide Navigation System (955-NC-NC), CranialClaronav2025-02-05
K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITTBrainlab AG2025-01-28
K243657ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc.2025-01-24
K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.2025-01-17
K242480FLASH EVD System (10-0002)7D Surgical ULC2024-12-27
K242351Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc.2024-10-04
K233703Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc.2024-04-26
K233141SmartFrame ORClearPoint Neuro, Inc.2024-01-12