Neurology · 510(k) · 2025
ClearPoint System (Software Version 3.0)
ClearPoint Neuro, Inc.. Cleared by FDA on 24 January 2025 under submission K243657, product code HAW (neurological stereotaxic instrument). What FDA's record says, in FDA's words.
Device record · K243657
- Device. ClearPoint System (Software Version 3.0)DEVICE
- Company. ClearPoint Neuro, Inc.COMPANY
- Decision. 24 January 2025, 510(k), substantially equivalent (traditional review); received 27 November 2024DECISION
- Panel. NeurologyPANEL
- Product code. HAW, Neurological Stereotaxic InstrumentCODE
- Regulation. 21 CFR 882.4560, Class IIREG
- Source. FDA database entry · decision document (14 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within an operating room environment and in conjunction with MR and/or CT imaging. During planning, the system is intended to provide functionality for the automatic identification, labeling, visualization, and quantification of segmentable brain structures from a set of loaded MR images. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion including deep brain stimulation (DBS) (asleep or awake) lead placement. When used in an MRI environment, the system is intended for use only with 1.5 and
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT, MRI
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 42,962 reports filed against devices carrying product code HAW. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · StealthStation¿ S8 system · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01386
Medtronic received information regarding a Navigation system being used outside of a procedure. It was reported that an inaccuracy was experienced while working with 2 different instruments in the same case. The application team found that the issue was with the end user (human issue). After that they verified the accuracy using demo sample. It was reported that all instruments were accurate and that the issue was with the end user. The amount of the inaccuracy was 10 mm, but it was not […]
30 September 2026 · Malfunction · StealthStation¿ S8 system · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01389
Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that the system had wear on the main power cable to the system. The grey coating was changing to white. There were no tears and no cable showing. There was no patient involvement.
30 September 2026 · Malfunction · StealthStation¿ S8 system · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01390
30 September 2026 · Malfunction · brand not stated · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01391
29 September 2026 · Malfunction · StealthStation¿ S8 system · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01382
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code HAW, in Neurology, from ClearPoint Neuro, Inc., or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.