ARVIS Surgical Navigation System— 510(k) K203115
Substantially EquivalentInsight Medical Systems, Inc.
FDA 510(k) clearance K203115 for ARVIS Surgical Navigation System, Substantially Equivalent on 2021-07-14. Applicant: Insight Medical Systems, Inc..
Clearance details
- Applicant
- Insight Medical Systems, Inc.
- Product code
- Code OLO
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Laguna Hills, CA, US
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.