SmartFrame OR
FDA 510(k) K233141 · ClearPoint Neuro, Inc.
510(k) numberK233141
Submission
- Device name
- SmartFrame OR
- Applicant
- ClearPoint Neuro, Inc.
Solana Beach, CA, US - Received
- September 27, 2023
- Decision date
- January 12, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | Elekta Solutions AB | 08/05/2026SE |
| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | Medtronic Navigation, Inc. | 03/26/2026SE |
| K231897 | NeuroAlign softwareHAW · Traditional | Medivis, Inc. | 10/21/2025SE |
| K251317 | SOLOPASS 2.0 SystemHAW · Traditional | Intravent Medical Partners | 09/05/2025SE |
| 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 |
|---|---|---|
| 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 |
| K233243 | ClearPoint System (Software Version 2.2)HAW · Traditional | 11/27/2023SE |
| K232102 | ClearPoint Array System (Version 1.2)HAW · Special | 09/15/2023SE |
| 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 SmartFrame OR cleared by the FDA?
SmartFrame OR (K233141) received a 510(k) decision of Substantially Equivalent on January 12, 2024, 107 days after the submission was received.
What is the product code of K233141?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.