da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
FDA 510(k) clearance K173906 · decided 2018-05-31
Clearance details
- K-number
- K173906
- Device name
- da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
- Applicant
- Intuitive Surgical, Inc.
- Decision
- Unknown
- Date received
- 2017-12-22
- Decision date
- 2018-05-31
- Days to decision
- 160 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| da Vinci Surgical System, Model IS5000 (K261824) | Intuitive Surgical, Inc. | 2026-07-31 |
| da Vinci Firefly Imaging System (K260695) | Intuitive Surgical | 2026-05-22 |
| Senhance Ultrasonic System (K254192) | Asensus Surgical | 2026-05-12 |
| da Vinci Force Feedback Instruments (K253986) | Intuitive Surgical, Inc. | 2026-03-11 |
| da Vinci Surgical System (IS5000) (K251739) | Intuitive Surgical, Inc. | 2026-01-16 |
| 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 SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 recall (Z-2722-2026) | Intuitive Surgical, Inc. | 2026-07-10 |
| Da Vinci ASSY, PSS, SP1098, Part Number: 380601 recall (Z-2521-2026) | Intuitive Surgical, Inc. | 2026-06-22 |
| Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098 recall (Z-1518-2024) | Intuitive Surgical, Inc. | 2024-04-11 |
| da Vinci SP surgical system recall (Z-2260-2020) | Intuitive Surgical, Inc. | 2020-06-03 |