POINT Kinguide Agile Robotic Arm Surgical Stereotactic System— 510(k) K252755
Substantially EquivalentPoint Robotics MedTech, Inc.
FDA 510(k) clearance K252755 for POINT Kinguide Agile Robotic Arm Surgical Stereotactic System, Substantially Equivalent on 2026-01-23. Applicant: Point Robotics MedTech, Inc..
Clearance details
- Applicant
- Point Robotics MedTech, Inc.
- Product code
- Code OLO
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Taipei City, TW
Adverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.