ClearPoint System and Accessories
FDA 510(k) K200079 · Mri Interventions, Inc.
510(k) numberK200079
Submission
- Device name
- ClearPoint System and Accessories
- Applicant
- Mri Interventions, Inc.
Irvine, CA, US - Received
- January 14, 2020
- Decision date
- February 13, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K191701 | Arcus Head Fixation FrameHBL · Traditional | 11/15/2019SE |
| K191400 | Voyager Trajectory Array Guide (V-TAG)HAW · Special | 06/21/2019SE |
| K181731 | MR Compatible Aspiration KitGWG · Traditional | 11/20/2018SE |
| K181195 | ClearPoint SystemORR · Traditional | 11/02/2018SE |
| K171257 | ClearPoint SystemORR · Traditional | 10/20/2017SE |
| K160129 | MRII Cranial Drill and AccessoriesHBG · Special | 03/26/2016SE |
| K160434 | ClearPoint SystemHAW · Special | 03/17/2016SE |
| K142505 | ClearPoint SystemHAW · Traditional | 10/21/2015SE |
| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmHBG · Special | 07/08/2015SE |
| K132436 | Varioguide Drill KitHBE · Traditional | 03/20/2014SE |
Questions and answers
When was ClearPoint System and Accessories cleared by the FDA?
ClearPoint System and Accessories (K200079) received a 510(k) decision of Substantially Equivalent on February 13, 2020, 30 days after the submission was received.
What is the product code of K200079?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.