Point Robotics MedTech, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252989 | POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set | February 20, 2026 |
| K252755 | POINT Kinguide Agile Robotic Arm Surgical Stereotactic System | January 23, 2026 |
| K241130 | POINT Kinguide Agile Hybrid Navigation System (PSHF01-000) | July 24, 2024 |
| K230087 | POINT Kinguide Agile Hybrid Navigation System | July 17, 2023 |
| K220241 | POINT Kinguide Robotic-Assisted Surgical System | August 9, 2022 |