Product code NAY
- Device name
- System, Surgical, Computer Controlled Instrument
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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).
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261824 | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | 2026-07-31 |
| K260695 | da Vinci Firefly Imaging System | Intuitive Surgical | 2026-05-22 |
| K254192 | Senhance Ultrasonic System | Asensus Surgical | 2026-05-12 |
| K253986 | da Vinci Force Feedback Instruments | Intuitive Surgical, Inc. | 2026-03-11 |
| K251739 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2026-01-16 |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | Intuitive Surgical, Inc. | 2026-01-16 |
| K252675 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-12-15 |
| K252069 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-12-02 |
| K251426 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-10-03 |
| K251817 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-09-10 |
| K251227 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2025-09-08 |
| K251324 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-08-29 |
| K252350 | da Vinci SP Firefly Imaging System | Intuitive Surgical, Inc. | 2025-08-28 |
| K250442 | da Vinci Surgical System, IS5000 | Intuitive Surgical, Inc. | 2025-07-29 |
| K251213 | Da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2025-07-23 |
| K251202 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2025-07-16 |
| K250674 | Vessel Sealer Curved (480522) | Intuitive Surgical, Inc. | 2025-06-13 |
| K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) | Intuitive Surgical, Inc. | 2025-06-11 |
| K250786 | SP Endoscope, 0° (430600) | Intuitive Surgical, Inc. | 2025-05-13 |
| K243714 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-04-24 |
| K242427 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | 2025-04-01 |
| K243582 | da Vinci SP Advanced Access Port Kit (432701) | Intuitive Surgical, Inc. | 2025-02-28 |
| K243641 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2024-12-16 |
| K242318 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2024-11-26 |
| K241814 | da Vinci SP Instruments (SP1098) | Intuitive Surgical, Inc. | 2024-11-18 |
| K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads | Intuitive Surgical, Inc. | 2024-09-10 |
| K233866 | Senhance Surgical System | Asensus Surgical, Inc. | 2024-07-19 |
| K240502 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2024-07-08 |
| K241284 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2024-07-03 |
| K232773 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2024-06-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00886874121924 | Sureform | INTUITIVE SURGICAL, INC. | 2022-05-11 |
| 00886874121931 | Sureform | INTUITIVE SURGICAL, INC. | 2022-05-11 |
| 00886874121917 | Sureform | INTUITIVE SURGICAL, INC. | 2022-05-11 |
| 00815440021887 | Senhance | Asensus Surgical, Inc. | 2019-08-01 |
| 00815440021641 | Senhance | Asensus Surgical, Inc. | 2019-02-04 |
| 00815440021634 | Senhance | Asensus Surgical, Inc. | 2019-02-04 |
| 00815440021627 | Senhance | Asensus Surgical, Inc. | 2019-02-04 |
| 00815440021696 | Senhance | Asensus Surgical, Inc. | 2018-11-02 |
| 00815440021689 | Senhance | Asensus Surgical, Inc. | 2018-11-02 |
| 00815440021672 | Senhance | Asensus Surgical, Inc. | 2018-11-02 |
| 00815440021665 | Senhance | Asensus Surgical, Inc. | 2018-11-02 |
| 00815440021658 | Senhance | Asensus Surgical, Inc. | 2018-11-02 |
| 00815440020682 | Senhance | Asensus Surgical, Inc. | 2018-11-02 |
| 00815440020705 | Senhance | Asensus Surgical, Inc. | 2018-11-02 |
| 00815440020798 | Senhance | Asensus Surgical, Inc. | 2018-11-02 |
| 00815440021252 | Senhance | Asensus Surgical, Inc. | 2018-11-02 |
| 00815440021238 | Senhance | Asensus Surgical, Inc. | 2018-11-02 |
| 00815440021245 | Senhance | Asensus Surgical, Inc. | 2018-11-02 |
| 00815440020828 | Senhance | Asensus Surgical, Inc. | 2017-11-27 |
| 00815440020163 | Senhance | Asensus Surgical, Inc. | 2017-11-27 |
| 00815440020170 | Senhance | Asensus Surgical, Inc. | 2017-11-27 |
| 00815440020811 | Senhance | Asensus Surgical, Inc. | 2017-11-27 |
| 00815440020804 | Senhance | Asensus Surgical, Inc. | 2017-11-27 |
| 00815440020781 | Senhance | Asensus Surgical, Inc. | 2017-11-27 |
| 00815440020231 | Senhance | Asensus Surgical, Inc. | 2017-11-27 |
| 00815440020224 | Senhance | Asensus Surgical, Inc. | 2017-11-27 |
| 00815440020217 | Senhance | Asensus Surgical, Inc. | 2017-11-27 |
| 00815440020200 | Senhance | Asensus Surgical, Inc. | 2017-11-27 |
| 00815440020194 | Senhance | Asensus Surgical, Inc. | 2017-11-27 |
| 00815440020187 | Senhance | Asensus Surgical, Inc. | 2017-11-27 |