Intuitive Surgical
FDA 510(k) & PMA Approved Devices — 14 products
Total Devices14
Categories4
Latest FDA decision2026-05-22
SEC Filings: 1 filings on record. Latest: 10-Q (2026-07-21). View on SEC EDGAR →
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260695 | da Vinci Firefly Imaging System | NAY | 2026-05-22 | View |
| 510(k) | K241635 | da Vinci E-200 Electrosurgical Generator | GEI | 2024-08-05 | View |
| 510(k) | K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | GEI | 2024-08-02 | View |
| 510(k) | K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | NAY | 2024-05-24 | View |
| 510(k) | K231212 | da Vinci E-200 Electrosurgical Generator | GEI | 2023-06-21 | View |
| 510(k) | K223039 | da Vinci E-200 Electrosurgical Generator | GEI | 2022-11-28 | View |
| 510(k) | K192803 | da Vinci Xi Surgical System, da Vinci X Surgical System | NAY | 2020-04-29 | View |
| 510(k) | K191529 | da Vinci Xi Surgical System, da Vinci X Surgical System | NAY | 2020-02-06 | View |
| 510(k) | K191736 | da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 | NAY | 2019-07-26 | View |
| 510(k) | K182643 | IRIS 1.0 System | LLZ | 2019-02-22 | View |
| 510(k) | K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | EOQ | 2019-02-14 | View |
| 510(k) | K183224 | SureForm 45, SureForm 45 Reloads | NAY | 2019-01-18 | View |
| 510(k) | K173721 | SureForm 60 and SureForm 60 Reloads | NAY | 2018-07-05 | View |
| 510(k) | K152892 | da Vinci Xi Surgical System | NAY | 2016-04-29 | View |
No matching devices.
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