Intuitive Surgical, Inc.
FDA 510(k) & PMA Approved Devices — 110 products
Total Devices110
Categories7
Latest FDA decision2026-08-07
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000) | FDS | 2026-08-07 | View |
| 510(k) | K261824 | da Vinci Surgical System, Model IS5000 | NAY | 2026-07-31 | View |
| 510(k) | K261249 | Universal Seal (5-12 mm) | GCJ | 2026-07-14 | View |
| 510(k) | K253986 | da Vinci Force Feedback Instruments | NAY | 2026-03-11 | View |
| 510(k) | K253978 | Universal Seal (5-12 mm) | GCJ | 2026-02-24 | View |
| 510(k) | K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | NAY | 2026-01-16 | View |
| 510(k) | K251739 | da Vinci Surgical System (IS5000) | NAY | 2026-01-16 | View |
| 510(k) | K251763 | IRISeg | QIH | 2025-12-16 | View |
| 510(k) | K252675 | da Vinci SP Surgical System (SP1098) | NAY | 2025-12-15 | View |
| 510(k) | K252069 | da Vinci SP Surgical System (SP1098) | NAY | 2025-12-02 | View |
| 510(k) | K251426 | da Vinci SP Surgical System (SP1098) | NAY | 2025-10-03 | View |
| 510(k) | K252045 | Ion Endoluminal System (IF1000) | EOQ | 2025-09-23 | View |
| 510(k) | K251817 | da Vinci SP Surgical System (SP1098) | NAY | 2025-09-10 | View |
| 510(k) | K251227 | da Vinci Surgical System (IS5000) | NAY | 2025-09-08 | View |
| 510(k) | K252528 | Ion Endoluminal System (IF1000) | EOQ | 2025-09-05 | View |
| 510(k) | K251324 | da Vinci SP Surgical System (SP1098) | NAY | 2025-08-29 | View |
| 510(k) | K252350 | da Vinci SP Firefly Imaging System | NAY | 2025-08-28 | View |
| 510(k) | K250442 | da Vinci Surgical System, IS5000 | NAY | 2025-07-29 | View |
| 510(k) | K251213 | Da Vinci Surgical System (IS5000) | NAY | 2025-07-23 | View |
| 510(k) | K251202 | da Vinci Surgical System (IS5000) | NAY | 2025-07-16 | View |
No matching devices.
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