ClearPoint Array System (Version 1.2)
FDA 510(k) K232102 · ClearPoint Neuro, Inc.
510(k) numberK232102
Submission
- Device name
- ClearPoint Array System (Version 1.2)
- Applicant
- ClearPoint Neuro, Inc.
Irvine, CA, US - Received
- July 14, 2023
- Decision date
- September 15, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
| K250505 | Ez-FiducialsHAW · Traditional | Phasor Health, LLC | 07/09/2025SE |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional | Brain Navi Biotechnology Co., Ltd. | 05/23/2025SE |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
More from Claronav
| 510(k) | Device | Decision |
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| K243657 | ClearPoint System (Software Version 3.0)HAW · Traditional | 01/24/2025SE |
| K233703 | Bone Anchor (NGS-BA-01)HAW · Traditional | 04/26/2024SE |
| K233155 | ClearPointer Optical Navigation WandHAW · Traditional | 01/12/2024SE |
| K233144 | ClearPoint Bone Screw FiducialsHAW · Traditional | 01/12/2024SE |
| K233141 | SmartFrame ORHAW · Traditional | 01/12/2024SE |
| K233243 | ClearPoint System (Software Version 2.2)HAW · Traditional | 11/27/2023SE |
| K222519 | ClearPoint SystemHAW · Special | 09/16/2022SE |
| K213645 | ClearPoint Maestro Brain ModelQIH · Traditional | 08/08/2022SE |
| K214040 | ClearPoint Array System (version 1.1)HAW · Traditional | 04/12/2022SE |
| K202575 | ClearPoint Array SystemHAW · Traditional | 01/22/2021SE |
Questions and answers
When was ClearPoint Array System (Version 1.2) cleared by the FDA?
ClearPoint Array System (Version 1.2) (K232102) received a 510(k) decision of Substantially Equivalent on September 15, 2023, 63 days after the submission was received.
What is the product code of K232102?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.