da Vinci X Surgical System
FDA 510(k) clearance K171294 · decided 2017-05-26
Clearance details
- K-number
- K171294
- Device name
- da Vinci X Surgical System
- Applicant
- Intuitive Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-05-02
- Decision date
- 2017-05-26
- Days to decision
- 24 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Intuitive Surgical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
|---|---|---|
| Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/ recall (Z-2046-2026) | Intuitive Surgical, Inc. | 2026-05-01 |
| Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical S recall (Z-1232-2026) | Intuitive Surgical, Inc. | 2026-02-02 |
| da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200 recall (Z-1293-2023) | Intuitive Surgical, Inc. | 2023-03-28 |
| Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgi recall (Z-1262-2023) | Intuitive Surgical, Inc. | 2023-03-16 |
| da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Co recall (Z-0133-2023) | Intuitive Surgical, Inc. | 2022-10-25 |