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 |
|---|---|---|---|
| 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 |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | Intuitive Surgical, Inc. | 2026-01-16 |
| K251739 | da Vinci Surgical System (IS5000) | 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 |
| K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | Intuitive Surgical | 2024-05-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860004977384 | StitchKit | ORIGAMI SURGICAL LLC | 2024-02-14 |
| 00860004977377 | StitchKit | ORIGAMI SURGICAL LLC | 2024-02-14 |
| 00860004977322 | StitchKit | ORIGAMI SURGICAL LLC | 2024-02-14 |
| 00860004977353 | StitchKit | ORIGAMI SURGICAL LLC | 2023-03-28 |
| 00860004977346 | StitchKit | ORIGAMI SURGICAL LLC | 2023-03-28 |
| 00860004977339 | StitchKit | ORIGAMI SURGICAL LLC | 2023-03-28 |
| 00860004977315 | StitchKit | ORIGAMI SURGICAL LLC | 2023-03-28 |
| 00860004977308 | StitchKit | ORIGAMI SURGICAL LLC | 2023-03-28 |
| 10886874116941 | None | INTUITIVE SURGICAL, INC. | 2018-10-11 |
| 10886874116934 | da Vinci Xi Surgical System | INTUITIVE SURGICAL, INC. | 2018-09-25 |
| 10886874114343 | None | INTUITIVE SURGICAL, INC. | 2018-09-20 |
| 00886874115374 | da Vinci Xi | INTUITIVE SURGICAL, INC. | 2017-11-01 |
| 00886874115404 | daVinci X | INTUITIVE SURGICAL, INC. | 2017-06-06 |
| 00748426077373 | MICROTEK | Microtek Medical LLC | 2016-11-16 |
| 10886874115234 | EndoWrist | INTUITIVE SURGICAL, INC. | 2016-10-17 |
| 00886874111031 | None | INTUITIVE SURGICAL, INC. | 2016-08-03 |
| 00886874110447 | None | INTUITIVE SURGICAL, INC. | 2016-07-08 |
| 00886874110997 | None | INTUITIVE SURGICAL, INC. | 2016-07-08 |
| 00886874110881 | daVinci Si | INTUITIVE SURGICAL, INC. | 2016-07-08 |
| 00886874111109 | EndoWrist;daVinci Si | INTUITIVE SURGICAL, INC. | 2016-07-08 |
| 00886874111017 | None | INTUITIVE SURGICAL, INC. | 2016-07-08 |
| 00886874111048 | None | INTUITIVE SURGICAL, INC. | 2016-07-08 |
| 00886874110720 | daVinci Xi | INTUITIVE SURGICAL, INC. | 2016-07-08 |
| 00886874110218 | None | INTUITIVE SURGICAL, INC. | 2016-07-08 |
| 00886874110201 | None | INTUITIVE SURGICAL, INC. | 2016-07-08 |
| 00886874112342 | EndoWrist | INTUITIVE SURGICAL, INC. | 2016-07-08 |
| 00886874112298 | EndoWrist | INTUITIVE SURGICAL, INC. | 2016-07-08 |
| 00886874110898 | daVinci Xi | INTUITIVE SURGICAL, INC. | 2016-07-08 |
| 00886874110744 | daVinci Xi | INTUITIVE SURGICAL, INC. | 2016-07-08 |
| 00886874110010 | None | INTUITIVE SURGICAL, INC. | 2016-06-18 |