FDA Product Code
FDA Product Code NAY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 166 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261823 | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | 2026-09-08 | Traditional | PDF ↗ |
| K261824 | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | 2026-07-31 | Traditional | PDF ↗ |
| K260695 | da Vinci Firefly Imaging System | Intuitive Surgical | 2026-05-22 | Traditional | PDF ↗ |
| K254192 | Senhance Ultrasonic System | Asensus Surgical | 2026-05-12 | Traditional | PDF ↗ |
| K253986 | da Vinci Force Feedback Instruments | Intuitive Surgical, Inc. | 2026-03-11 | Traditional | PDF ↗ |
| K251739 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2026-01-16 | Traditional | PDF ↗ |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | Intuitive Surgical, Inc. | 2026-01-16 | Traditional | PDF ↗ |
| K252675 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-12-15 | Traditional | PDF ↗ |
| K252069 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-12-02 | Traditional | PDF ↗ |
| K251426 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-10-03 | Traditional | PDF ↗ |
| K251817 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-09-10 | Traditional | PDF ↗ |
| K251227 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2025-09-08 | Traditional | PDF ↗ |
| K251324 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-08-29 | Traditional | PDF ↗ |
| K252350 | da Vinci SP Firefly Imaging System | Intuitive Surgical, Inc. | 2025-08-28 | Special | PDF ↗ |
| K250442 | da Vinci Surgical System, IS5000 | Intuitive Surgical, Inc. | 2025-07-29 | Traditional | PDF ↗ |
| K251213 | Da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2025-07-23 | Traditional | PDF ↗ |
| K251202 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2025-07-16 | Traditional | PDF ↗ |
| K250674 | Vessel Sealer Curved (480522) | Intuitive Surgical, Inc. | 2025-06-13 | Traditional | PDF ↗ |
| K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) | Intuitive Surgical, Inc. | 2025-06-11 | Traditional | PDF ↗ |
| K250786 | SP Endoscope, 0° (430600) | Intuitive Surgical, Inc. | 2025-05-13 | Traditional | PDF ↗ |
| K243714 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-04-24 | Traditional | PDF ↗ |
| K242427 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | 2025-04-01 | Traditional | PDF ↗ |
| K243582 | da Vinci SP Advanced Access Port Kit (432701) | Intuitive Surgical, Inc. | 2025-02-28 | Traditional | PDF ↗ |
| K243641 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2024-12-16 | Traditional | PDF ↗ |
| K242318 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2024-11-26 | Traditional | PDF ↗ |
| K241814 | da Vinci SP Instruments (SP1098) | Intuitive Surgical, Inc. | 2024-11-18 | Traditional | PDF ↗ |
| K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads | Intuitive Surgical, Inc. | 2024-09-10 | Traditional | PDF ↗ |
| K233866 | Senhance Surgical System | Asensus Surgical, Inc. | 2024-07-19 | Traditional | PDF ↗ |
| K240502 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2024-07-08 | Traditional | PDF ↗ |
| K241284 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2024-07-03 | Traditional | PDF ↗ |
| K232773 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2024-06-04 | Traditional | PDF ↗ |
| K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | Intuitive Surgical | 2024-05-24 | Traditional | PDF ↗ |
| K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | Intuitive Surgical, Inc. | 2024-03-14 | Traditional | PDF ↗ |
| K231798 | da Vinci SP Surgical System | Intuitive Surgical, Inc. | 2023-11-08 | Traditional | PDF ↗ |
| K231224 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | 2023-05-12 | Special | PDF ↗ |
| K230033 | Da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2023-04-05 | Traditional | PDF ↗ |
| K223095 | Senhance Surgical System | Asensus Surgical, Inc. | 2023-03-16 | Traditional | PDF ↗ |
| K222839 | EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System | Intuitive Surgical, Inc. | 2023-03-16 | Special | PDF ↗ |
| K223080 | da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) | Intuitive Surgical, Inc. | 2022-11-22 | Traditional | PDF ↗ |
| K222827 | da Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2022-10-20 | Special | PDF ↗ |
| K214095 | da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments | Intuitive Surgical, Inc. | 2022-08-15 | Traditional | PDF ↗ |
| K220889 | Senhance Surgical System | Asensus Surgical, Inc. | 2022-05-27 | Special | PDF ↗ |
| K213710 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2022-02-17 | Traditional | PDF ↗ |
| K220023 | 8mm Monopolar Curved Scissors | Intuitive Surgical, Inc. | 2022-01-31 | Special | PDF ↗ |
| K211997 | 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads | Intuitive Surgical, Inc. | 2021-12-10 | Traditional | PDF ↗ |
| K212101 | da Vinci SP Firefly Imaging System | Intuitive Surgical, Inc. | 2021-11-23 | Traditional | PDF ↗ |
| K212747 | Da Vinci SP Surgical System | Intuitive Surgical, Inc. | 2021-09-29 | Special | PDF ↗ |
| K212054 | Senhance Surgical System | Asensus Surgical, Inc. | 2021-08-30 | Traditional | PDF ↗ |
| K211784 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | 2021-08-06 | Traditional | PDF ↗ |
| K211325 | Senhance Surgical System | Asensus Surgical, Inc. | 2021-07-27 | Traditional | PDF ↗ |
| K211316 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2021-07-23 | Traditional | PDF ↗ |
| K211595 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2021-06-23 | Special | PDF ↗ |
| K210918 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2021-04-26 | Special | PDF ↗ |
| K202166 | Senhance Surgical System | Transenterix, Inc. | 2021-03-02 | Traditional | PDF ↗ |
| K203632 | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments | Intuitive Surgical, Inc. | 2021-02-10 | Traditional | PDF ↗ |
| K200473 | SoloAsisst II, Voice Control | Aktormed GmbH | 2020-12-22 | Traditional | PDF ↗ |
| K202968 | Da Vinci SP Surgical System | Intuitive Surgical, Inc. | 2020-12-22 | Traditional | PDF ↗ |
| K202834 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | 2020-12-10 | Traditional | PDF ↗ |
| K202571 | da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories | Intuitive Surgical, Inc. | 2020-11-12 | Traditional | PDF ↗ |
| K192717 | da Vinci SP Surgical System | Intuitive Surgical, Inc. | 2020-09-28 | Traditional | PDF ↗ |
| K192803 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical | 2020-04-29 | Traditional | PDF ↗ |
| K183086 | da Vinci X and Xi Surgical System | Intuitive Surgical, Inc. | 2020-03-31 | Traditional | PDF ↗ |
| K200049 | Senhance Surgical System | Transenterix, Inc. | 2020-03-09 | Traditional | PDF ↗ |
| K191529 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical | 2020-02-06 | Traditional | PDF ↗ |
| K192877 | Senhance Surgical System | Transenterix, Inc. | 2019-11-22 | Special | PDF ↗ |
| K191280 | E-100 Electrosurgical Generator, SynchroSeal | Intuitive Surgical, Inc. | 2019-11-14 | Traditional | PDF ↗ |
| K191736 | da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 | Intuitive Surgical | 2019-07-26 | Special | PDF ↗ |
| K190999 | SureForm 45 Curved Tip, SureForm 45 Gray Reload | Intuitive Surgical, Inc. | 2019-07-12 | Traditional | PDF ↗ |
| K191482 | Senhance Surgical System | Transenterix, Inc. | 2019-07-11 | Special | PDF ↗ |
| K182371 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | Intuitive Surgical, Inc. | 2019-03-14 | Traditional | PDF ↗ |
| K183224 | SureForm 45, SureForm 45 Reloads | Intuitive Surgical | 2019-01-18 | Traditional | PDF ↗ |
| K182421 | Senhance Ultrasonic System | Transenterix, Inc. | 2019-01-11 | Traditional | PDF ↗ |
| K183107 | Intuitive Surgical Vessel Sealer Extend | Intuitive Surgical, Inc. | 2018-12-11 | Traditional | PDF ↗ |
| K183098 | Senhance Surgical System | Transenterix, Inc. | 2018-12-06 | Special | PDF ↗ |
| K182140 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | 2018-10-24 | Traditional | PDF ↗ |
| K181517 | Senhance Surgical System | Transenterix, Inc. | 2018-10-09 | Traditional | PDF ↗ |
| K171947 | SOLOASSIST II | Aktormed GmbH | 2018-09-21 | Traditional | PDF ↗ |
| K180351 | EndoWrist Mercury Bipolar Grasper | Intuitive Surgical, Inc. | 2018-08-07 | Traditional | PDF ↗ |
| K173585 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | 2018-07-19 | Traditional | PDF ↗ |
| K173721 | SureForm 60 and SureForm 60 Reloads | Intuitive Surgical | 2018-07-05 | Traditional | PDF ↗ |
| K173415 | EndoWrist 5mm Thoracic Grasper | Intuitive Surgical, Inc. | 2018-05-31 | Traditional | PDF ↗ |
| K173906 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | Intuitive Surgical, Inc. | 2018-05-31 | Traditional | PDF ↗ |
| K180163 | TransEnterix Senhance Surgical System | Transenterix, Inc. | 2018-05-25 | Traditional | PDF ↗ |
| K173337 | Intuitive Surgical EndoWrist Vessel Sealer Extend | Intuitive Surgical, Inc. | 2018-04-26 | Traditional | PDF ↗ |
| K173842 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | 2018-04-23 | Traditional | PDF ↗ |
| K180033 | 8mm Monopolar Curved Scissors | Intuitive Surgical, Inc. | 2018-04-06 | Traditional | PDF ↗ |
| K172643 | da Vinci Xi Surgical System; da Vinci X Surgical System | Intuitive Surgical, Inc. | 2018-01-31 | Traditional | PDF ↗ |
| K171120 | Senhance Surgical Robotic System | Transenterix, Inc. | 2017-10-13 | Traditional | PDF ↗ |
| K170641 | da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes | Intuitive Surgical, Inc. | 2017-09-21 | Traditional | PDF ↗ |
| K170879 | IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories | Intuitive Surgical, Inc. | 2017-09-21 | Traditional | PDF ↗ |
| K171632 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | 2017-09-19 | Traditional | PDF ↗ |
| K170875 | da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories | Intuitive Surgical, Inc. | 2017-09-12 | Traditional | PDF ↗ |
| K170645 | da Vinci Xi EndoWrist Instruments and Accessories | Intuitive Surgical, Inc. | 2017-09-11 | Traditional | PDF ↗ |
| K170644 | da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) | Intuitive Surgical, Inc. | 2017-09-11 | Traditional | PDF ↗ |
| K171699 | da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | 2017-07-28 | Traditional | PDF ↗ |
| K170713 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | 2017-06-13 | Traditional | PDF ↗ |
| K171426 | da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree | Intuitive Surgical, Inc. | 2017-06-13 | Special | PDF ↗ |
| K171388 | EndoWrist Stapler 45 System and Stapler 45 Reloads | Intuitive Surgical, Inc. | 2017-05-31 | Special | PDF ↗ |
| K171294 | da Vinci X Surgical System | Intuitive Surgical, Inc. | 2017-05-26 | Special | PDF ↗ |
| K170865 | EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories | Intuitive Surgical, Inc. | 2017-04-21 | Traditional | PDF ↗ |
Product code NAY · Class II · Gastroenterology, Urology. Data: openFDA.