Panels › Gastroenterology, Urology › Product code NAY · Class 2
System, Surgical, Computer Controlled Instrument
Regulation 876.1500
9510(k)s in 12 months (166 all time)
16recalls in 12 months (248 all time)
244recalls that name a 510(k)
Top companies in NAY
| Company | 510(k)s | Recalls |
|---|---|---|
| Intuitive Surgical | 147 | 246 |
| Transenterix, Inc. | 9 | 0 |
| Asensus Surgical | 6 | 1 |
| Aktormed GmbH | 2 | 0 |
| Computer Motion, Inc. | 2 | 0 |
| Olympus Corporation of the Americas | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 8, 2026 | K261823 | da Vinci Surgical System, Model IS5000 Intuitive Surgical, Inc. | NAY |
| Jul 31, 2026 | K261824 | da Vinci Surgical System, Model IS5000 Intuitive Surgical, Inc. | NAY |
| May 22, 2026 | K260695 | da Vinci Firefly Imaging System Intuitive Surgical | NAY |
| May 12, 2026 | K254192 | Senhance Ultrasonic System Asensus Surgical | NAY |
| Mar 11, 2026 | K253986 | da Vinci Force Feedback Instruments Intuitive Surgical, Inc. | NAY |
| Jan 16, 2026 | K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator Intuitive Surgical, Inc. | NAY |
| Jan 16, 2026 | K251739 | da Vinci Surgical System (IS5000) Intuitive Surgical, Inc. | NAY |
| Dec 15, 2025 | K252675 | da Vinci SP Surgical System (SP1098) Intuitive Surgical, Inc. | NAY |
| Dec 2, 2025 | K252069 | da Vinci SP Surgical System (SP1098) Intuitive Surgical, Inc. | NAY |
| Oct 3, 2025 | K251426 | da Vinci SP Surgical System (SP1098) Intuitive Surgical, Inc. | NAY |
| Sep 10, 2025 | K251817 | da Vinci SP Surgical System (SP1098) Intuitive Surgical, Inc. | NAY |
| Sep 8, 2025 | K251227 | da Vinci Surgical System (IS5000) Intuitive Surgical, Inc. | NAY |
| Aug 29, 2025 | K251324 | da Vinci SP Surgical System (SP1098) Intuitive Surgical, Inc. | NAY |
| Aug 28, 2025 | K252350 | da Vinci SP Firefly Imaging System Intuitive Surgical, Inc. | NAY |
| Jul 29, 2025 | K250442 | da Vinci Surgical System, IS5000 Intuitive Surgical, Inc. | NAY |
| Jul 23, 2025 | K251213 | Da Vinci Surgical System (IS5000) Intuitive Surgical, Inc. | NAY |
| Jul 16, 2025 | K251202 | da Vinci Surgical System (IS5000) Intuitive Surgical, Inc. | NAY |
| Jun 13, 2025 | K250674 | Vessel Sealer Curved (480522) Intuitive Surgical, Inc. | NAY |
| Jun 11, 2025 | K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) Intuitive Surgical, Inc. | NAY |
| May 13, 2025 | K250786 | SP Endoscope, 0° (430600) Intuitive Surgical, Inc. | NAY |
| Apr 24, 2025 | K243714 | da Vinci SP Surgical System (SP1098) Intuitive Surgical, Inc. | NAY |
| Apr 1, 2025 | K242427 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) Intuitive Surgical, Inc. | NAY |
| Feb 28, 2025 | K243582 | da Vinci SP Advanced Access Port Kit (432701) Intuitive Surgical, Inc. | NAY |
| Dec 16, 2024 | K243641 | da Vinci Surgical System (IS5000) Intuitive Surgical, Inc. | NAY |
| Nov 26, 2024 | K242318 | da Vinci SP Surgical System (SP1098) Intuitive Surgical, Inc. | NAY |
| Nov 18, 2024 | K241814 | da Vinci SP Instruments (SP1098) Intuitive Surgical, Inc. | NAY |
| Sep 10, 2024 | K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads Intuitive Surgical, Inc. | NAY |
| Jul 19, 2024 | K233866 | Senhance Surgical System Asensus Surgical, Inc. | NAY |
| Jul 8, 2024 | K240502 | da Vinci SP Surgical System (SP1098) Intuitive Surgical, Inc. | NAY |
| Jul 3, 2024 | K241284 | da Vinci Surgical System (IS5000) Intuitive Surgical, Inc. | NAY |
| Jun 4, 2024 | K232773 | da Vinci SP Surgical System (SP1098) Intuitive Surgical, Inc. | NAY |
| May 24, 2024 | K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) Intuitive Surgical | NAY |
| Mar 14, 2024 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation Intuitive Surgical, Inc. | NAY |
| Nov 8, 2023 | K231798 | da Vinci SP Surgical System Intuitive Surgical, Inc. | NAY |
| May 12, 2023 | K231224 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) Intuitive Surgical, Inc. | NAY |
| Apr 5, 2023 | K230033 | Da Vinci SP Surgical System (SP1098) Intuitive Surgical, Inc. | NAY |
| Mar 16, 2023 | K223095 | Senhance Surgical System Asensus Surgical, Inc. | NAY |
| Mar 16, 2023 | K222839 | EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 Syste Intuitive Surgical, Inc. | NAY |
| Nov 22, 2022 | K223080 | da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) Intuitive Surgical, Inc. | NAY |
| Oct 20, 2022 | K222827 | da Vinci Firefly Imaging System Intuitive Surgical, Inc. | NAY |
| Aug 15, 2022 | K214095 | da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments Intuitive Surgical, Inc. | NAY |
| May 27, 2022 | K220889 | Senhance Surgical System Asensus Surgical, Inc. | NAY |
| Feb 17, 2022 | K213710 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System Intuitive Surgical, Inc. | NAY |
| Jan 31, 2022 | K220023 | 8mm Monopolar Curved Scissors Intuitive Surgical, Inc. | NAY |
| Dec 10, 2021 | K211997 | 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads Intuitive Surgical, Inc. | NAY |
| Nov 23, 2021 | K212101 | da Vinci SP Firefly Imaging System Intuitive Surgical, Inc. | NAY |
| Sep 29, 2021 | K212747 | Da Vinci SP Surgical System Intuitive Surgical, Inc. | NAY |
| Aug 30, 2021 | K212054 | Senhance Surgical System Asensus Surgical, Inc. | NAY |
| Aug 6, 2021 | K211784 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) Intuitive Surgical, Inc. | NAY |
| Jul 27, 2021 | K211325 | Senhance Surgical System Asensus Surgical, Inc. | NAY |
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