da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation— 510(k) K232610
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K232610 for da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation, Substantially Equivalent on 2024-03-14. Applicant: Intuitive Surgical, Inc..
Clearance details
- Applicant
- Intuitive Surgical, Inc.
- Product code
- Code NAY
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Adverse events under product code NAY
product code NAY- Death
- 433
- Injury
- 7,927
- Malfunction
- 93,790
- Other
- 19
- Total
- 102,169
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.