FDA.reportPublic FDA data

510(k) K243698

Device
Alignment 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 LITT
Applicant
Brainlab AG
510(k) number
K243698
Product code
HAW
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-28
Date received
2024-11-29
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
No

Applicant Contact#

Contact
Esther Moreno Garcia
Address
Olof-Palme St. 9 Munich DE 81829 81829

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HAW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253663Zeta Navigation SystemZeta Surgical, Inc.2026-05-01
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K251317SOLOPASS 2.0 SystemIntravent Medical Partners2025-09-05
K250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.2025-09-04
K250505EZ-FIDUCIALSPhasor Health, LLC2025-07-09
K242575Stereotaxic Guiding Surgical Devices, NaoTrac SBrain Navi Biotechnology Co., Ltd.2025-05-23
K241327Navient Image Guide Navigation System (955-NC-NC), CranialClaronav2025-02-05
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
K233144ClearPoint Bone Screw FiducialsClearPoint Neuro, Inc.2024-01-12
K233141SmartFrame ORClearPoint Neuro, Inc.2024-01-12