POINT Kinguide Agile Hybrid Navigation System (PSHF01-000)— 510(k) K241130
Substantially EquivalentPoint Robotics MedTech, Inc.
FDA 510(k) clearance K241130 for POINT Kinguide Agile Hybrid Navigation System (PSHF01-000), Substantially Equivalent on 2024-07-24. 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.