FDA.reportPublic FDA data

510(k) K223577

Device
Localite TMS Navigator TS
Applicant
Localite GmbH
510(k) number
K223577
Product code
HAW
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-17
Date received
2022-11-30
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
No

Applicant Contact#

Contact
Arno Schmitgen
Address
Auguststr. 1 Bonn DE 53229 53229

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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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
K233155ClearPointer Optical Navigation WandClearPoint Neuro, Inc.2024-01-12