NAY
- Product code
- NAY
- Device name
- System, Surgical, Computer Controlled Instrument
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 33
- Summaries archived here
- 27 (direct download)
- 510(k) clearances (all years, FDA)
- 165 (all years; only the last 3 years are listed here)
FDA classification definition
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).
510(k) clearances, last 3 years (33)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261824 | 2026-07-31 | Intuitive Surgical, Inc. | da Vinci Surgical System, Model IS5000 | |
| K260695 | 2026-05-22 | Intuitive Surgical | da Vinci Firefly Imaging System | |
| K254192 | 2026-05-12 | Asensus Surgical | Senhance Ultrasonic System | |
| K253986 | 2026-03-11 | Intuitive Surgical, Inc. | da Vinci Force Feedback Instruments | FDA |
| K251739 | 2026-01-16 | Intuitive Surgical, Inc. | da Vinci Surgical System (IS5000) | |
| K253556 | 2026-01-16 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098); da Vinci E-200… | FDA |
| K252675 | 2025-12-15 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098) | |
| K252069 | 2025-12-02 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098) | FDA |
| K251426 | 2025-10-03 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098) | |
| K251817 | 2025-09-10 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098) | |
| K251227 | 2025-09-08 | Intuitive Surgical, Inc. | da Vinci Surgical System (IS5000) | |
| K251324 | 2025-08-29 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098) | |
| K252350 | 2025-08-28 | Intuitive Surgical, Inc. | da Vinci SP Firefly Imaging System | |
| K250442 | 2025-07-29 | Intuitive Surgical, Inc. | da Vinci Surgical System, IS5000 | |
| K251213 | 2025-07-23 | Intuitive Surgical, Inc. | Da Vinci Surgical System (IS5000) | |
| K251202 | 2025-07-16 | Intuitive Surgical, Inc. | da Vinci Surgical System (IS5000) | |
| K250674 | 2025-06-13 | Intuitive Surgical, Inc. | Vessel Sealer Curved (480522) | |
| K240852 | 2025-06-11 | Intuitive Surgical, Inc. | da Vinci X Surgical System (IS4200); da Vinci Xi Sur… | |
| K250786 | 2025-05-13 | Intuitive Surgical, Inc. | SP Endoscope, 0° (430600) | |
| K243714 | 2025-04-24 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098) | |
| K242427 | 2025-04-01 | Intuitive Surgical, Inc. | da Vinci Xi Surgical System (IS4000); da Vinci X Sur… | |
| K243582 | 2025-02-28 | Intuitive Surgical, Inc. | da Vinci SP Advanced Access Port Kit (432701) | |
| K243641 | 2024-12-16 | Intuitive Surgical, Inc. | da Vinci Surgical System (IS5000) | |
| K242318 | 2024-11-26 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098) | FDA |
| K241814 | 2024-11-18 | Intuitive Surgical, Inc. | da Vinci SP Instruments (SP1098) | FDA |
| K241638 | 2024-09-10 | Intuitive Surgical, Inc. | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 … | |
| K233866 | 2024-07-19 | Asensus Surgical, Inc. | Senhance Surgical System | |
| K240502 | 2024-07-08 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098) | |
| K241284 | 2024-07-03 | Intuitive Surgical, Inc. | da Vinci Surgical System (IS5000) | |
| K232773 | 2024-06-04 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098) | |
| K240723 | 2024-05-24 | Intuitive Surgical | da Vinci Xi Surgical System (IS4000); da Vinci X Sur… | |
| K232610 | 2024-03-14 | Intuitive Surgical, Inc. | da Vinci Surgical System Model IS5000, da Vinci Insu… | |
| K231798 | 2023-11-08 | Intuitive Surgical, Inc. | da Vinci SP Surgical System | FDA |
Official FDA classification page: NAY
Classification and pathway per current FDA publications. Data from openFDA (CC0).