da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
FDA 510(k) K173906 · Intuitive Surgical, Inc.
510(k) numberK173906
Submission
- Device name
- da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
- Applicant
- Intuitive Surgical, Inc.
Sunnyvale, CA, US - Received
- December 22, 2017
- Decision date
- May 31, 2018
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NAY – System, Surgical, Computer Controlled Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code NAY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261823 | da Vinci Surgical System, Model IS5000NAY · Traditional | Intuitive Surgical, Inc. | 09/08/2026SE |
| K261824 | da Vinci Surgical System, Model IS5000NAY · Traditional | Intuitive Surgical, Inc. | 07/31/2026SE |
| K260695 | da Vinci Firefly Imaging SystemNAY · Traditional | Intuitive Surgical | 05/22/2026SE |
| K254192 | Senhance Ultrasonic SystemNAY · Traditional | Asensus Surgical | 05/12/2026SE |
| K253986 | da Vinci Force Feedback InstrumentsNAY · Traditional | Intuitive Surgical, Inc. | 03/11/2026SE |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorNAY · Traditional | Intuitive Surgical, Inc. | 01/16/2026SE |
| K251739 | da Vinci Surgical System (IS5000)NAY · Traditional | Intuitive Surgical, Inc. | 01/16/2026SE |
| K252675 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 12/15/2025SE |
| K252069 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 12/02/2025SE |
| K251426 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 10/03/2025SE |
More from Intuitive Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261823 | da Vinci Surgical System, Model IS5000NAY · Traditional | 09/08/2026SE |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000)FDS · Traditional | 08/07/2026SE |
| K261824 | da Vinci Surgical System, Model IS5000NAY · Traditional | 07/31/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | 07/14/2026SE |
| K260695 | da Vinci Firefly Imaging SystemNAY · Traditional | 05/22/2026SE |
| K253986 | da Vinci Force Feedback InstrumentsNAY · Traditional | 03/11/2026SE |
| K253978 | Universal Seal (5-12 mm)GCJ · Traditional | 02/24/2026SE |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorNAY · Traditional | 01/16/2026SE |
| K251739 | da Vinci Surgical System (IS5000)NAY · Traditional | 01/16/2026SE |
| K251763 | IRISegQIH · Traditional | 12/16/2025SE |
Questions and answers
When was da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories cleared by the FDA?
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories (K173906) received a 510(k) decision of Unknown on May 31, 2018, 160 days after the submission was received.
What is the product code of K173906?
The FDA product code is NAY – System, Surgical, Computer Controlled Instrument, a Class II (moderate risk) device regulated under 21 CFR 876.1500.