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 |
|---|---|---|---|
| Jul 23, 2021 | K211316 | da Vinci SP Surgical System (SP1098) Intuitive Surgical, Inc. | NAY |
| Jun 23, 2021 | K211595 | da Vinci SP Surgical System (SP1098) Intuitive Surgical, Inc. | NAY |
| Apr 26, 2021 | K210918 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System Intuitive Surgical, Inc. | NAY |
| Mar 2, 2021 | K202166 | Senhance Surgical System Transenterix, Inc. | NAY |
| Feb 10, 2021 | K203632 | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments Intuitive Surgical, Inc. | NAY |
| Dec 22, 2020 | K202968 | Da Vinci SP Surgical System Intuitive Surgical, Inc. | NAY |
| Dec 22, 2020 | K200473 | SoloAsisst II, Voice Control Aktormed GmbH, DE | NAY |
| Dec 10, 2020 | K202834 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) Intuitive Surgical, Inc. | NAY |
| Nov 12, 2020 | K202571 | da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories Intuitive Surgical, Inc. | NAY |
| Sep 28, 2020 | K192717 | da Vinci SP Surgical System Intuitive Surgical, Inc. | NAY |
| Apr 29, 2020 | K192803 | da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical | NAY |
| Mar 31, 2020 | K183086 | da Vinci X and Xi Surgical System Intuitive Surgical, Inc. | NAY |
| Mar 9, 2020 | K200049 | Senhance Surgical System Transenterix, Inc. | NAY |
| Feb 6, 2020 | K191529 | da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical | NAY |
| Nov 22, 2019 | K192877 | Senhance Surgical System Transenterix, Inc. | NAY |
| Nov 14, 2019 | K191280 | E-100 Electrosurgical Generator, SynchroSeal Intuitive Surgical, Inc. | NAY |
| Jul 26, 2019 | K191736 | da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 Intuitive Surgical | NAY |
| Jul 12, 2019 | K190999 | SureForm 45 Curved Tip, SureForm 45 Gray Reload Intuitive Surgical, Inc. | NAY |
| Jul 11, 2019 | K191482 | Senhance Surgical System Transenterix, Inc. | NAY |
| Mar 14, 2019 | K182371 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories Intuitive Surgical, Inc. | NAY |
| Jan 18, 2019 | K183224 | SureForm 45, SureForm 45 Reloads Intuitive Surgical | NAY |
| Jan 11, 2019 | K182421 | Senhance Ultrasonic System Transenterix, Inc. | NAY |
| Dec 11, 2018 | K183107 | Intuitive Surgical Vessel Sealer Extend Intuitive Surgical, Inc. | NAY |
| Dec 6, 2018 | K183098 | Senhance Surgical System Transenterix, Inc. | NAY |
| Oct 24, 2018 | K182140 | da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical, Inc. | NAY |
| Oct 9, 2018 | K181517 | Senhance Surgical System Transenterix, Inc. | NAY |
| Sep 21, 2018 | K171947 | SOLOASSIST II Aktormed GmbH, DE | NAY |
| Aug 7, 2018 | K180351 | EndoWrist Mercury Bipolar Grasper Intuitive Surgical, Inc. | NAY |
| Jul 19, 2018 | K173585 | da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical, Inc. | NAY |
| Jul 5, 2018 | K173721 | SureForm 60 and SureForm 60 Reloads Intuitive Surgical | NAY |
| May 31, 2018 | K173906 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories Intuitive Surgical, Inc. | NAY |
| May 31, 2018 | K173415 | EndoWrist 5mm Thoracic Grasper Intuitive Surgical, Inc. | NAY |
| May 25, 2018 | K180163 | TransEnterix Senhance Surgical System Transenterix, Inc. | NAY |
| Apr 26, 2018 | K173337 | Intuitive Surgical EndoWrist Vessel Sealer Extend Intuitive Surgical, Inc. | NAY |
| Apr 23, 2018 | K173842 | da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical, Inc. | NAY |
| Apr 6, 2018 | K180033 | 8mm Monopolar Curved Scissors Intuitive Surgical, Inc. | NAY |
| Jan 31, 2018 | K172643 | da Vinci Xi Surgical System; da Vinci X Surgical System Intuitive Surgical, Inc. | NAY |
| Oct 13, 2017 | K171120 | Senhance Surgical Robotic System Transenterix, Inc. | NAY |
| Sep 21, 2017 | K170879 | IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Ins Intuitive Surgical, Inc. | NAY |
| Sep 21, 2017 | K170641 | da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes Intuitive Surgical, Inc. | NAY |
| Sep 19, 2017 | K171632 | da Vinci Xi Surgical System Intuitive Surgical, Inc. | NAY |
| Sep 12, 2017 | K170875 | da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories Intuitive Surgical, Inc. | NAY |
| Sep 11, 2017 | K170645 | da Vinci Xi EndoWrist Instruments and Accessories Intuitive Surgical, Inc. | NAY |
| Sep 11, 2017 | K170644 | da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) Intuitive Surgical, Inc. | NAY |
| Jul 28, 2017 | K171699 | da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System Intuitive Surgical, Inc. | NAY |
| Jun 13, 2017 | K171426 | da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree Intuitive Surgical, Inc. | NAY |
| Jun 13, 2017 | K170713 | da Vinci Xi Surgical System Intuitive Surgical, Inc. | NAY |
| May 31, 2017 | K171388 | EndoWrist Stapler 45 System and Stapler 45 Reloads Intuitive Surgical, Inc. | NAY |
| May 26, 2017 | K171294 | da Vinci X Surgical System Intuitive Surgical, Inc. | NAY |
| Apr 21, 2017 | K170865 | EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories Intuitive Surgical, Inc. | NAY |
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