Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list ClearPoint Neuro, Inc. with 11 510(k) clearances and 3 AI-enabled devices. The most recent is a 510(k) clearance dated Jan 24, 2025: ClearPoint System (Software Version 3.0).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 24, 2025 | ClearPoint System (Software Version 3.0)K243657 · HAW | 510(k) clearances |
| Jan 24, 2025 | ClearPoint System (Software Version 3.0)K243657 · Neurology | AI-enabled devices |
| Nov 13, 2024 | SmartFlow Neuro CannulaDEN240023 · SDG | 510(k) clearances |
| Apr 26, 2024 | Bone Anchor (NGS-BA-01)K233703 · HAW | 510(k) clearances |
| Jan 12, 2024 | ClearPoint Bone Screw FiducialsK233144 · HAW | 510(k) clearances |
| Jan 12, 2024 | ClearPointer Optical Navigation WandK233155 · HAW | 510(k) clearances |
| Jan 12, 2024 | SmartFrame ORK233141 · HAW | 510(k) clearances |
| Nov 27, 2023 | ClearPoint System (Software Version 2.2)K233243 · HAW | 510(k) clearances |
| Nov 27, 2023 | ClearPoint System (Software Version 2.2)K233243 · Neurology | AI-enabled devices |
| Sep 15, 2023 | ClearPoint Array System (Version 1.2)K232102 · HAW | 510(k) clearances |
| Aug 8, 2022 | ClearPoint Maestro Brain ModelK213645 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
