DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000
FDA 510(k) clearance K063220 · decided 2006-12-01
Clearance details
- K-number
- K063220
- Device name
- DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000
- Applicant
- Intuitive Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-24
- Decision date
- 2006-12-01
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- NAY
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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| da Vinci Surgical System, Model IS5000 (K261824) | Intuitive Surgical, Inc. | 2026-07-31 |
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| da Vinci Force Feedback Instruments (K253986) | Intuitive Surgical, Inc. | 2026-03-11 |
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| da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator (K253556) | Intuitive Surgical, Inc. | 2026-01-16 |
| da Vinci SP Surgical System (SP1098) (K252675) | Intuitive Surgical, Inc. | 2025-12-15 |
| da Vinci SP Surgical System (SP1098) (K252069) | Intuitive Surgical, Inc. | 2025-12-02 |
| da Vinci SP Surgical System (SP1098) (K251426) | Intuitive Surgical, Inc. | 2025-10-03 |
| da Vinci SP Surgical System (SP1098) (K251817) | Intuitive Surgical, Inc. | 2025-09-10 |
| da Vinci Surgical System (IS5000) (K251227) | Intuitive Surgical, Inc. | 2025-09-08 |
| da Vinci SP Surgical System (SP1098) (K251324) | Intuitive Surgical, Inc. | 2025-08-29 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems. Intuitive Sur recall (Z-1202-2012) | Intuitive Surgical, Inc. | 2012-03-13 |
| Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS recall (Z-0151-2008) | Intuitive Surgical, Inc. | 2008-02-22 |
| Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS recall (Z-0152-2008) | Intuitive Surgical, Inc. | 2008-02-22 |
| daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit recall (Z-1245-2007) | Intuitive Surgical, Inc. | 2007-09-26 |