da Vinci Force Feedback Instruments— 510(k) K253986
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K253986 for da Vinci Force Feedback Instruments, Substantially Equivalent on 2026-03-11. Applicant: Intuitive Surgical, Inc.. Device class: 2.
Summary
Intuitive Surgical's da Vinci Force Feedback Instruments are filed under NAY, computer-controlled surgical instrument systems. The record doesn't list the individual instruments.
Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.
Intuitive Surgical filed from Sunnyvale, California. The decision came 89 calendar days after FDA received it (December 12, 2025 to March 11, 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.