da Vinci Surgical System, Model IS5000— 510(k) K261823
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K261823 for da Vinci Surgical System, Model IS5000, Substantially Equivalent on 2026-09-08. Applicant: Intuitive Surgical, Inc.. Device class: 2.
Summary
Intuitive Surgical's da Vinci Surgical System, Model IS5000, is filed under NAY, computer-controlled surgical instrument systems. The record doesn't say which instruments or procedures this clearance covers.
Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k); the record lists Gastroenterology and Urology as the classification panel.
Intuitive filed from Sunnyvale, California. Review took 99 calendar days (June 1 to September 8, 2026).
Clearance details
- Applicant
- Intuitive Surgical, Inc.
- Product code
- Product code NAY
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code NAY
view allMore clearances from Intuitive Surgical, Inc.
view allAdverse 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.