Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3028006458

FEI Number

3028006458

Entity Name

ClearPoint Neuro Inc.

City/State/Country

Carlsbad, CA, US

Establishment Address

6349 Paseo Del Lago, Carlsbad, CA 92011, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ClearPoint Neuro, Inc. (Owner Number: 9038590)

Owner / Operator Contact Address

120 S Sierra Ave, Solana Beach, CA 92075, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233141

PMA Number

N/A

All Registered Proprietary Names

SmartFlow Loading Fixture VARIOGUIDE DRILL KIT Bone Screw Fiducials ClearPoint System (Software Version 3) SmartFlow Neuro Cannula MRI Neuro Drape ClearPoint System (Software Version 2) IRRAflow Long Extension IMRIS 1.5T Inflexion Head Frame SmartTwist MRI Hand Drill, SmartTip Drill Bit Kit Mobile Equipment Cart IRRAflow Active Fluid Exchange System (AFES) IRRAflow Bolt Bladed Lancet Cranial Access Kit Flexible Self Adhesive Equipment Cover SF M6 BOLT DRIVER MR Hex Key Bone Anchor Head Fixation Arc ClearPoint Array System (Version 1.2) ClearPoint Pursuit SmartFrame OR System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2026-01-08
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2023-04-17
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-03-08
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-02-03
SDG	Brain Intraparenchymal Infusion Cannula	Neurology	Class 2	882.4110	2024-11-20
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2009-11-13
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-12-02
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2026-01-08
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2026-01-08
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2011-11-01
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2019-12-03
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2022-09-19
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2016-11-04
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2024-05-10
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2026-01-08
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2026-01-08
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2026-01-08
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2024-06-20
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2026-01-08
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2024-07-18
LRZ	Screwdriver, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-06-20
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-05-10
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2009-11-13
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-10-06
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2018-12-17
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-03-08

Official Correspondent

Megan Faulkenberry

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ClearPoint Neuro, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03
K092467	Brainlab AG	VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED	2010-05-06
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Z-0007-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3028006458. Last updated year: 2026. Please use registration number 3028006458 when referencing this establishment in official correspondence.