Data / Medical devices / United States / ClearPoint Neuro Inc.
ClearPoint Neuro Inc.: FDA-registered device maker in Carlsbad, CA, United States, 22 510(k) clearances
ClearPoint Neuro Inc. is registered with the FDA (registration 3028006458) in Carlsbad, CA, United States. It lists 17 device types. The FDA files 22 510(k) clearances under its listings, the newest dated January 24, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3028006458
- Address
- 6349 Paseo Del Lago, Carlsbad, CA, United States, 92011
- Owner or operator
- ClearPoint Neuro, Inc. (9038590)
- Roles
- Manufacturer
- First device listed
- November 13, 2009
- Registered through
- 2026
- Brand names listed
- Bladed Lancet, Bone Anchor, Bone Screw Fiducials, ClearPoint Array System (Version 1.2), ClearPoint Pursuit, ClearPoint System (Software Version 2), ClearPoint System (Software Version 3), ClearPointer Optical Navigation Wand and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 24, 2025 | K243657 | ClearPoint System (Software Version 3.0) | HAW | Substantially Equivalent | ClearPoint Neuro, Inc. | accessdata.fda.gov |
| November 13, 2024 | DEN240023 | SmartFlow Neuro Cannula | SDG | Unknown | ClearPoint Neuro, Inc. | accessdata.fda.gov |
| April 26, 2024 | K233703 | Bone Anchor (NGS-BA-01) | HAW | Substantially Equivalent | ClearPoint Neuro, Inc. | accessdata.fda.gov |
| January 12, 2024 | K233155 | ClearPointer Optical Navigation Wand | HAW | Substantially Equivalent | ClearPoint Neuro, Inc. | accessdata.fda.gov |
| January 12, 2024 | K233144 | ClearPoint Bone Screw Fiducials | HAW | Substantially Equivalent | ClearPoint Neuro, Inc. | accessdata.fda.gov |
| January 12, 2024 | K233141 | SmartFrame OR | HAW | Substantially Equivalent | ClearPoint Neuro, Inc. | accessdata.fda.gov |
| October 19, 2023 | K231664 | IRRAflow Active Fluid Exchange System (AFES) | JXG | Substantially Equivalent | Irras USA, Inc. | accessdata.fda.gov |
| September 15, 2023 | K232102 | ClearPoint Array System (Version 1.2) | HAW | Substantially Equivalent | ClearPoint Neuro, Inc. | accessdata.fda.gov |
| August 8, 2022 | K213645 | ClearPoint Maestro Brain Model | QIH | Substantially Equivalent | ClearPoint Neuro, Inc. | accessdata.fda.gov |
| February 13, 2020 | K200079 | ClearPoint System and Accessories | HAW | Substantially Equivalent | Mri Interventions, Inc. | accessdata.fda.gov |
| November 15, 2019 | K191701 | Arcus Head Fixation Frame | HBL | Substantially Equivalent | Mri Interventions, Inc. | accessdata.fda.gov |
| November 20, 2018 | K181731 | MR Compatible Aspiration Kit | GWG | Substantially Equivalent | Mri Interventions, Inc. | accessdata.fda.gov |
| July 13, 2018 | K171880 | IRRAflow CNS System | JXG | Substantially Equivalent | Irras, Inc. | accessdata.fda.gov |
| March 26, 2016 | K160129 | MRII Cranial Drill and Accessories | HBG | Substantially Equivalent | Mri Interventions, Inc. | accessdata.fda.gov |
| March 20, 2014 | K132436 | VARIOGUIDE DRILL KIT | HBE | Substantially Equivalent | Mri Interventions, Inc. | accessdata.fda.gov |
| September 8, 2011 | K111802 | SV BRAIN ARRAY, SIEMENS 3T | MOS | Substantially Equivalent | Mri Interventions, Inc. | accessdata.fda.gov |
| January 26, 2011 | K102101 | SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA | HCD | Substantially Equivalent | Surgivision, Inc. | accessdata.fda.gov |
| September 29, 2009 | K083378 | SYNERGY | GWM | Substantially Equivalent | Innerspace, Inc. | accessdata.fda.gov |
| September 22, 2009 | K091343 | MRI NEURO DRAPE | KKX | Substantially Equivalent | Surgivision, Inc. | accessdata.fda.gov |
| August 25, 2009 | K091439 | HEAD FIXATION ARC AND TABLE BASE | HBL | Substantially Equivalent | Surgivision, Inc. | accessdata.fda.gov |
| March 16, 2009 | K090267 | SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64 | MOS | Substantially Equivalent | Midwest Rf, LLC | accessdata.fda.gov |
| June 5, 1996 | K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL | HBG | Substantially Equivalent | Clinical Neuro Systems, LLC | accessdata.fda.gov |
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Updated January 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.