System, Surgical, Computer Controlled Instrument
FDA product code NAY · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
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).
166510(k) clearances
0PMA approvals
248recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261823 | da Vinci Surgical System, Model IS5000NAY · Traditional | Intuitive Surgical, Inc. | 09/08/2026SE |
| K261824 | da Vinci Surgical System, Model IS5000NAY · Traditional | Intuitive Surgical, Inc. | 07/31/2026SE |
| K260695 | da Vinci Firefly Imaging SystemNAY · Traditional | Intuitive Surgical | 05/22/2026SE |
| K254192 | Senhance Ultrasonic SystemNAY · Traditional | Asensus Surgical | 05/12/2026SE |
| K253986 | da Vinci Force Feedback InstrumentsNAY · Traditional | Intuitive Surgical, Inc. | 03/11/2026SE |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorNAY · Traditional | Intuitive Surgical, Inc. | 01/16/2026SE |
| K251739 | da Vinci Surgical System (IS5000)NAY · Traditional | Intuitive Surgical, Inc. | 01/16/2026SE |
| K252675 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 12/15/2025SE |
| K252069 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 12/02/2025SE |
| K251426 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 10/03/2025SE |
| K251817 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 09/10/2025SE |
| K251227 | da Vinci Surgical System (IS5000)NAY · Traditional | Intuitive Surgical, Inc. | 09/08/2025SE |
| K251324 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 08/29/2025SE |
| K252350 | da Vinci SP Firefly Imaging SystemNAY · Special | Intuitive Surgical, Inc. | 08/28/2025SE |
| K250442 | da Vinci Surgical System, IS5000NAY · Traditional | Intuitive Surgical, Inc. | 07/29/2025SE |
| K251213 | Da Vinci Surgical System (IS5000)NAY · Traditional | Intuitive Surgical, Inc. | 07/23/2025SE |
| K251202 | da Vinci Surgical System (IS5000)NAY · Traditional | Intuitive Surgical, Inc. | 07/16/2025SE |
| K250674 | Vessel Sealer Curved (480522)NAY · Traditional | Intuitive Surgical, Inc. | 06/13/2025SE |
| K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)NAY · Traditional | Intuitive Surgical, Inc. | 06/11/2025SE |
| K250786 | SP Endoscope, 0° (430600)NAY · Traditional | Intuitive Surgical, Inc. | 05/13/2025SE |
| K243714 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 04/24/2025SE |
| K242427 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)NAY · Traditional | Intuitive Surgical, Inc. | 04/01/2025SE |
| K243582 | da Vinci SP Advanced Access Port Kit (432701)NAY · Traditional | Intuitive Surgical, Inc. | 02/28/2025SE |
| K243641 | da Vinci Surgical System (IS5000)NAY · Traditional | Intuitive Surgical, Inc. | 12/16/2024SE |
| K242318 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 11/26/2024SESU |
| K241814 | da Vinci SP Instruments (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 11/18/2024SESU |
| K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 ReloadsNAY · Traditional | Intuitive Surgical, Inc. | 09/10/2024SE |
| K233866 | Senhance Surgical SystemNAY · Traditional | Asensus Surgical, Inc. | 07/19/2024SE |
| K240502 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 07/08/2024SESU |
| K241284 | da Vinci Surgical System (IS5000)NAY · Traditional | Intuitive Surgical, Inc. | 07/03/2024SE |
| K232773 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 06/04/2024SE |
| K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)NAY · Traditional | Intuitive Surgical | 05/24/2024SE |
| K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…NAY · Traditional | Intuitive Surgical, Inc. | 03/14/2024SE |
| K231798 | da Vinci SP Surgical SystemNAY · Traditional | Intuitive Surgical, Inc. | 11/08/2023SESU |
| K231224 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)NAY · Special | Intuitive Surgical, Inc. | 05/12/2023SE |
| K230033 | Da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 04/05/2023SESU |
| K223095 | Senhance Surgical SystemNAY · Traditional | Asensus Surgical, Inc. | 03/16/2023SE |
| K222839 | EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm…NAY · Special | Intuitive Surgical, Inc. | 03/16/2023SE |
| K223080 | da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)NAY · Traditional | Intuitive Surgical, Inc. | 11/22/2022SE |
| K222827 | da Vinci Firefly Imaging SystemNAY · Special | Intuitive Surgical, Inc. | 10/20/2022SE |
| K214095 | da Vinci X/Xi (IS4200/IS4000) 8mm Reusable InstrumentsNAY · Traditional | Intuitive Surgical, Inc. | 08/15/2022SE |
| K220889 | Senhance Surgical SystemNAY · Special | Asensus Surgical, Inc. | 05/27/2022SE |
| K213710 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemNAY · Traditional | Intuitive Surgical, Inc. | 02/17/2022SE |
| K220023 | 8mm Monopolar Curved ScissorsNAY · Special | Intuitive Surgical, Inc. | 01/31/2022SE |
| K211997 | 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 ReloadsNAY · Traditional | Intuitive Surgical, Inc. | 12/10/2021SE |
| K212101 | da Vinci SP Firefly Imaging SystemNAY · Traditional | Intuitive Surgical, Inc. | 11/23/2021SE |
| K212747 | Da Vinci SP Surgical SystemNAY · Special | Intuitive Surgical, Inc. | 09/29/2021SESU |
| K212054 | Senhance Surgical SystemNAY · Traditional | Asensus Surgical, Inc. | 08/30/2021SE |
| K211784 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)NAY · Traditional | Intuitive Surgical, Inc. | 08/06/2021SE |
| K211325 | Senhance Surgical SystemNAY · Traditional | Asensus Surgical, Inc. | 07/27/2021SE |
| K211316 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 07/23/2021SESU |
| K211595 | da Vinci SP Surgical System (SP1098)NAY · Special | Intuitive Surgical, Inc. | 06/23/2021SESU |
| K210918 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemNAY · Special | Intuitive Surgical, Inc. | 04/26/2021SE |
| K202166 | Senhance Surgical SystemNAY · Traditional | Transenterix, Inc. | 03/02/2021SE |
| K203632 | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X…NAY · Traditional | Intuitive Surgical, Inc. | 02/10/2021SE |
| K202968 | Da Vinci SP Surgical SystemNAY · Traditional | Intuitive Surgical, Inc. | 12/22/2020SESU |
| K200473 | SoloAsisst II, Voice ControlNAY · Traditional | Aktormed GmbH | 12/22/2020SE |
| K202834 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)NAY · Traditional | Intuitive Surgical, Inc. | 12/10/2020SE |
| K202571 | da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesNAY · Traditional | Intuitive Surgical, Inc. | 11/12/2020SESU |
| K192717 | da Vinci SP Surgical SystemNAY · Traditional | Intuitive Surgical, Inc. | 09/28/2020SESU |
| K192803 | da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY · Traditional | Intuitive Surgical | 04/29/2020SE |
| K183086 | da Vinci X and Xi Surgical SystemNAY · Traditional | Intuitive Surgical, Inc. | 03/31/2020SE |
| K200049 | Senhance Surgical SystemNAY · Traditional | Transenterix, Inc. | 03/09/2020SE |
| K191529 | da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY · Traditional | Intuitive Surgical | 02/06/2020SE |
| K192877 | Senhance Surgical SystemNAY · Special | Transenterix, Inc. | 11/22/2019SE |
| K191280 | E-100 Electrosurgical Generator, SynchroSealNAY · Traditional | Intuitive Surgical, Inc. | 11/14/2019SE |
| K191736 | da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30NAY · Special | Intuitive Surgical | 07/26/2019SE |
| K190999 | SureForm 45 Curved Tip, SureForm 45 Gray ReloadNAY · Traditional | Intuitive Surgical, Inc. | 07/12/2019SE |
| K191482 | Senhance Surgical SystemNAY · Special | Transenterix, Inc. | 07/11/2019SE |
| K182371 | da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY · Traditional | Intuitive Surgical, Inc. | 03/14/2019SESU |
| K183224 | SureForm 45, SureForm 45 ReloadsNAY · Traditional | Intuitive Surgical | 01/18/2019SE |
| K182421 | Senhance Ultrasonic SystemNAY · Traditional | Transenterix, Inc. | 01/11/2019SE |
| K183107 | Intuitive Surgical Vessel Sealer ExtendNAY · Traditional | Intuitive Surgical, Inc. | 12/11/2018SE |
| K183098 | Senhance Surgical SystemNAY · Special | Transenterix, Inc. | 12/06/2018SE |
| K182140 | da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY · Traditional | Intuitive Surgical, Inc. | 10/24/2018SE |
| K181517 | Senhance Surgical SystemNAY · Traditional | Transenterix, Inc. | 10/09/2018SE |
| K171947 | Soloassist IINAY · Traditional | Aktormed GmbH | 09/21/2018SE |
| K180351 | EndoWrist Mercury Bipolar GrasperNAY · Traditional | Intuitive Surgical, Inc. | 08/07/2018SE |
| K173585 | da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY · Traditional | Intuitive Surgical, Inc. | 07/19/2018SE |
| K173721 | SureForm 60 and SureForm 60 ReloadsNAY · Traditional | Intuitive Surgical | 07/05/2018SE |
| K173906 | da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY · Traditional | Intuitive Surgical, Inc. | 05/31/2018SESU |
| K173415 | EndoWrist 5mm Thoracic GrasperNAY · Traditional | Intuitive Surgical, Inc. | 05/31/2018SE |
| K180163 | TransEnterix Senhance Surgical SystemNAY · Traditional | Transenterix, Inc. | 05/25/2018SE |
| K173337 | Intuitive Surgical EndoWrist Vessel Sealer ExtendNAY · Traditional | Intuitive Surgical, Inc. | 04/26/2018SE |
| K173842 | da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY · Traditional | Intuitive Surgical, Inc. | 04/23/2018SE |
| K180033 | 8mm Monopolar Curved ScissorsNAY · Traditional | Intuitive Surgical, Inc. | 04/06/2018SE |
| K172643 | da Vinci Xi Surgical System; da Vinci X Surgical SystemNAY · Traditional | Intuitive Surgical, Inc. | 01/31/2018SE |
| K171120 | Senhance Surgical Robotic SystemNAY · Traditional | Transenterix, Inc. | 10/13/2017SE |
| K170879 | IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30…NAY · Traditional | Intuitive Surgical, Inc. | 09/21/2017SE |
| K170641 | da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesNAY · Traditional | Intuitive Surgical, Inc. | 09/21/2017SE |
| K171632 | da Vinci Xi Surgical SystemNAY · Traditional | Intuitive Surgical, Inc. | 09/19/2017SE |
| K170875 | da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments…NAY · Traditional | Intuitive Surgical, Inc. | 09/12/2017SE |
| K170645 | da Vinci Xi EndoWrist Instruments and AccessoriesNAY · Traditional | Intuitive Surgical, Inc. | 09/11/2017SE |
| K170644 | da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm &…NAY · Traditional | Intuitive Surgical, Inc. | 09/11/2017SE |
| K171699 | da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemNAY · Traditional | Intuitive Surgical, Inc. | 07/28/2017SE |
| K171426 | da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeNAY · Special | Intuitive Surgical, Inc. | 06/13/2017SE |
| K170713 | da Vinci Xi Surgical SystemNAY · Traditional | Intuitive Surgical, Inc. | 06/13/2017SE |
| K171388 | EndoWrist Stapler 45 System and Stapler 45 ReloadsNAY · Special | Intuitive Surgical, Inc. | 05/31/2017SE |
| K171294 | da Vinci X Surgical SystemNAY · Special | Intuitive Surgical, Inc. | 05/26/2017SE |
| K170865 | EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…NAY · Traditional | Intuitive Surgical, Inc. | 04/21/2017SE |
| K170508 | EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30…NAY · Traditional | Intuitive Surgical, Inc. | 03/10/2017SE |
| K162973 | EndoWrist Suction IrrigatorNAY · Traditional | Intuitive Surgical, Inc. | 02/06/2017SE |
| K161178 | da Vinci Xi Surgical SystemNAY · Traditional | Intuitive Surgical, Inc. | 01/19/2017SE |
| K162411 | da Vinci Xi 12 8 mm ReducerNAY · Special | Intuitive Surgical, Inc. | 09/21/2016SE |
| K153276 | da Vinci Xi Surgical SystemNAY · Traditional | Intuitive Surgical, Inc. | 08/07/2016SE |
| K161271 | da Vinci Xi Surgical SystemNAY · Special | Intuitive Surgical, Inc. | 07/11/2016SE |
| K152892 | da Vinci Xi Surgical SystemNAY · Traditional | Intuitive Surgical | 04/29/2016SE |
| K152578 | da Vinci Surgical System, Model IS4000NAY · Traditional | Intuitive Surgical, Inc. | 03/30/2016SE |
| K152448 | da Vinci Single-Site Instrument and AccessoriesNAY · Traditional | Intuitive Surgical, Inc. | 03/09/2016SE |
| K152421 | IS4000 Stapler 30 Instrument and Stapler 30 ReloadsNAY · Traditional | Intuitive Surgical, Inc. | 03/04/2016SE |
| K151794 | da Vinci Xi Surgical SystemNAY · Traditional | Intuitive Surgical, Inc. | 01/15/2016SE |
| K150284 | IS4000 da Vinci EndoWrist InstrumentsNAY · Special | Intuitive Surgical, Inc. | 05/15/2015SE |
| K150837 | IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsNAY · Special | Intuitive Surgical, Inc. | 04/29/2015SE |
| K143132 | IS4000 8mm Harmonic ACE Curved ShearsNAY · Traditional | Intuitive Surgical, Inc. | 04/02/2015SE |
| K142683 | 12 mm Endoscopes and AccessoriesNAY · Traditional | Intuitive Surgical, Inc. | 12/10/2014SE |
| K143217 | 12 mm & Stapler Bladeless ObturatorsNAY · Special | Intuitive Surgical, Inc. | 12/03/2014SE |
| K141075 | Single-Site Wristed Needle DriverNAY · Traditional | Intuitive Surgical | 09/26/2014SESU |
| K123329 | Da Vinvi Surgical SystemNAY · Traditional | Intuitive Surgical, Inc. | 09/17/2014SESU |
| K141077 | Da Vinci Firefly Imaging SystemNAY · Traditional | Intuitive Surgical, Inc. | 08/12/2014SE |
| K140553 | Endowrist Stapler 45 and Stapler 45 ReloadsNAY · Traditional | Intuitive Surgical, Inc. | 07/25/2014SE |
| K140189 | Endowrist Vessel SealerNAY · Traditional | Intuitive Surgical, Inc. | 06/05/2014SE |
| K131962 | Da Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesNAY · Traditional | Intuitive Surgical, Inc. | 04/17/2014SESU |
| K131861 | Da Vinci Surgical System, Endowrist Instruments and AccessoriesNAY · Traditional | Intuitive Surgical, Inc. | 03/28/2014SE |
| K130266 | Endowrist One Vessel SealerNAY · Traditional | Intuitive Surgical, Inc. | 08/29/2013SE |
| K122532 | Da Vinci Single-Site Instruments and AccessoriesNAY · Traditional | Intuitive Surgical, Inc. | 07/30/2013SESU |
| K130726 | Da Vinci Single-Site Permanent Cautery HookNAY · Special | Intuitive Surgical, Inc. | 06/07/2013SESU |
| K123840 | Connect for Da Vinci Surgical System(S)NAY · Special | Intuitive Surgical, Inc. | 02/14/2013SE |
| K123463 | Intuitive Surgical Da Vinci Si Surgical System SmartpedalsNAY · Special | Intuitive Surgical, Inc. | 12/03/2012SE |
| K121921 | Intuitive Surgical Onsite for Da Vinci Surgical SystemsNAY · Traditional | Intuitive Surgical, Inc. | 10/25/2012SE |
| K113706 | Endowrist Stapler SystemNAY · Traditional | Intuitive Surgical, Inc. | 10/17/2012SE |
| K120215 | Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…NAY · Special | Intuitive Surgical, Inc. | 04/30/2012SESU |
| K110639 | Endowrist One Vessel SealerNAY · Traditional | Intuitive Surgical, Inc. | 12/28/2011SE |
| K112208 | Intutive Surgical Da Vinci Single Site Instruments and AccessoriesNAY · Traditional | Intuitive Surgical, Inc. | 12/08/2011SESU |
| K112263 | Monopolar Curved Scissors Tip Cover AccessoryNAY · Special | Intuitive Surgical, Inc. | 10/07/2011SE |
| K112584 | 5MM/8MM Harmonic Ace(Tm) Curved Shears, Disposable Harmonic Ace(Tm) Insert, Disposable…NAY · Special | Intuitive Surgical, Inc. | 09/29/2011SE |
| K110451 | Endowrist One Suction/IrrigatorNAY · Traditional | Intuitive Surgical, Inc. | 08/26/2011SE |
| K101581 | Intuitive Surgical Da Vinci S Surgical System with Da Vinci Connect & Da Vinci Onsite…NAY · Traditional | Intuitive Surgical, Inc. | 04/08/2011SE |
| K101743 | 5MM Flared Cannula Model 420262, 8MM Flared Cannula Model 420319NAY · Traditional | Intuitive Surgical, Inc. | 02/04/2011SE |
| K093217 | 5 MM Harmonic Ace Instrument (Used with Da Vinci IS1200 & IS2000/IS3000 System)NAY · Traditional | Intuitive Surgical, Inc. | 01/21/2010SE |
| K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000NAY · Traditional | Intuitive Surgical, Inc. | 12/16/2009SE |
| K082497 | Intuitive Surgical Endowrist One Hot Shears InstrumentNAY · Traditional | Intuitive Surgical, Inc. | 05/07/2009SE |
| K081137 | Intuitive Surgical Da Vinci Si Surgical System: Model IS3000NAY · Traditional | Intuitive Surgical, Inc. | 02/18/2009SE |
| K081207 | Intuitive Surgical Da Vinci S Surgical System, Model IS2000, with Da Vinci Connect and…NAY · Traditional | Intuitive Surgical, Inc. | 12/19/2008SE |
| K080291 | Intuitive Surgical Da Vinci Endoscopic Instruments and Control System and Endowrist…NAY · Traditional | Intuitive Surgical, Inc. | 03/19/2008SE |
| K070947 | Intuitive Surgical Da Vinci Surgical System and Endoscopic Instruments and Endowrist…NAY · Traditional | Intuitive Surgical, Inc. | 02/14/2008SE |
| K072627 | Intuitive Surgical Da Vinci and Da Vinci S Surgical System and Endoscopic Instruments…NAY · Traditional | Intuitive Surgical, Inc. | 02/07/2008SE |
| K063220 | Da Vinci S Surgical SYSTEM-V1.1, Model IS2000NAY · Traditional | Intuitive Surgical, Inc. | 12/01/2006SE |
| K061260 | Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214NAY · Special | Intuitive Surgical, Inc. | 05/18/2006SE |
| K060391 | Intuitive Surgical Endowrist Stabilizer, Model 420182NAY · Special | Intuitive Surgical, Inc. | 04/10/2006SE |
| K050802 | Modification to Intuitive Surgical Da Vinci Surgical System and Endoscopic InstrumentsNAY · Traditional | Intuitive Surgical, Inc. | 06/29/2005SE |
| K050369 | Intuitive Surgical Da Vinci Surgical System, Model IS2000NAY · Traditional | Intuitive Surgical, Inc. | 04/29/2005SE |
| K043288 | Modification to Intuitive Surgical Da Vinci Surgical System and Endoscopic InstrumentsNAY · Traditional | Intuitive Surgical, Inc. | 03/03/2005SE |
| K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…NAY · Special | Intuitive Surgical, Inc. | 01/25/2005SE |
| K043153 | Intuitive Surgical Da Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…NAY · Special | Intuitive Surgical, Inc. | 12/15/2004SE |
| K042855 | Intuitive Surgical Harmonic Curved Shears InstrumentNAY · Special | Intuitive Surgical, Inc. | 11/12/2004SE |
| K040237 | Intuitive Surgical Da Vinci Endoscopic Instrument Control System and Endoscopic…NAY · Traditional | Intuitive Surgical, Inc. | 07/07/2004SE |
| K040948 | Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/N 400170NAY · Special | Intuitive Surgical, Inc. | 05/05/2004SE |
| K030578 | Bipolar Grasper and Bipolar Scissors for the Zeus Microwrist Surgical SystemNAY · Traditional | Computer Motion, Inc. | 06/24/2003SE |
| K022574 | Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…NAY · Traditional | Intuitive Surgical, Inc. | 11/12/2002SE |
| K021152 | Zeus Microwrist Robotic Surgical System and AccessoriesNAY · Traditional | Computer Motion, Inc. | 09/24/2002SE |
| K021036 | Intuitive Surgical Da Vinci Surgical System, Model IS1000NAY · Traditional | Intuitive Surgical, Inc. | 06/26/2002SE |
| K012833 | Intuitive Surgical Bipolar ForcepsNAY · Traditional | Intuitive Surgical, Inc. | 11/16/2001SE |
| K011281 | Intuitive Surgical Ultrasonic ShearsNAY · Traditional | Intuitive Surgical, Inc. | 07/24/2001SE |
| K011002 | Intuitive Surgical Da Vinci Surgical System, Model Isi 1000NAY · Traditional | Intuitive Surgical, Inc. | 05/30/2001SE |
| K002489 | Intuitive Surgical Da Vinci Endoscopic Control SystemNAY · Traditional | Intuitive Surgical, Inc. | 03/02/2001SE |
| K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…NAY · Traditional | Intuitive Surgical, Inc. | 07/11/2000SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2310-2026 Class II | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746…Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination… | Intuitive Surgical, Inc. | 04/24/2026Open, Classified |
| Z-2521-2026 Class II | Da Vinci ASSY, PSS, SP1098, Part Number: 380601Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a… | Intuitive Surgical, Inc. | 04/22/2026Open, Classified |
| Z-2046-2026 Class II | Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System…Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking. | Intuitive Surgical, Inc. | 04/02/2026Open, Classified |
| Z-1855-2026 Class I | Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06Reloads for curved-tipped stapler may potentially produce an incomplete staple line. | Intuitive Surgical, Inc. | 03/11/2026Open, Classified |
| Z-1355-2026 Class II | da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number:…Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss… | Intuitive Surgical, Inc. | 12/30/2025Open, Classified |
| Z-1096-2026 Class II | da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073…Access Port System tray may develop cracks potentially resulting in a sterility breach. | Intuitive Surgical, Inc. | 12/15/2025Open, Classified |
| Z-1701-2026 Class II | Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S…Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments | Intuitive Surgical, Inc. | 12/09/2025Open, Classified |
| Z-1700-2026 Class II | Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si…Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments | Intuitive Surgical, Inc. | 12/09/2025Open, Classified |
| Z-1699-2026 Class II | Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si…Due to increased complaints for broken/frayed grip cables for reusable instruments. | Intuitive Surgical, Inc. | 12/09/2025Open, Classified |
| Z-1698-2026 Class II | Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si…Due to increased complaints for broken/frayed grip cables for reusable instruments. | Intuitive Surgical, Inc. | 12/09/2025Open, Classified |
| Z-1697-2026 Class II | Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci…Due to increased complaints for broken/frayed grip cables for reusable instruments. | Intuitive Surgical, Inc. | 12/09/2025Open, Classified |
| Z-1696-2026 Class II | Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S…Due to increased complaints for broken/frayed grip cables for reusable instruments. | Intuitive Surgical, Inc. | 12/09/2025Open, Classified |
| Z-1428-2026 Class II | Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally…An error event following the release of a software version for the surgical system that can result in loss… | Intuitive Surgical, Inc. | 11/17/2025Open, Classified |
| Z-1232-2026 Class II | Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical…Due to a software implementation error that allowed instruments arms failing an important diagnostic test to… | Intuitive Surgical, Inc. | 11/07/2025Open, Classified |
| Z-2722-2026 Class II | da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the… | Intuitive Surgical, Inc. | 05/12/2025Open, Classified |
| Z-1325-2025 Class II | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals…Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining… | Intuitive Surgical, Inc. | 02/26/2025Open, Classified |
| Z-0924-2025 Class II | 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci…Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0923-2025 Class II | 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical…Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0883-2025 Class II | 8MM,FORCE BIPOLAR,IS4000 REF 471405Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0882-2025 Class II | 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0881-2025 Class II | 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0880-2025 Class II | 8MM,MEGA SUTURECUT ND,IS4000 REF 471309Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0879-2025 Class II | 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0878-2025 Class II | 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0877-2025 Class II | 8MM,COBRA GRASPER,IS4000 REF 471190Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0876-2025 Class II | 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0875-2025 Class II | 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0874-2025 Class II | 8MM,PROGRASP FORCEPS,IS4000 REF 471093Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0873-2025 Class II | 8MM,CADIERE FORCEPS,IS4000 REF 471049Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0872-2025 Class II | 8MM,LONG TIP FORCEPS,IS4000 REF 471048Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0871-2025 Class II | 8MM,FORCE BIPOLAR,IS4000 REF 470405Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0870-2025 Class II | 8MM,HORIZON SMALL CLIP APPLIER,IS4000 REF 470401Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0869-2025 Class II | 8MM,TIP-UP FENESTRATED GRASPER,IS4000 REF 470347Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0868-2025 Class II | 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 470344Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0867-2025 Class II | 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000 REF 470327Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0866-2025 Class II | 8MM,SMALL GRASPING RETRACTOR,IS4000 REF 470318Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0865-2025 Class II | 8MM,MEGA SUTURECUT ND,IS4000 REF 470309Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0864-2025 Class II | 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 470296Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0863-2025 Class II | 8MM,DUAL BLADE RETRACTOR,IS4000 REF 470249Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0862-2025 Class II | 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000 REF 470246Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0861-2025 Class II | 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000 REF 470230Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0860-2025 Class II | 8MM,TENACULUM FORCEPS,IS4000 REF 470207Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0859-2025 Class II | 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 470205Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0858-2025 Class II | 8MM,MEGA NEEDLE DRIVER,IS4000 REF 470194Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0857-2025 Class II | 8MM,RESANO FORCEPS,IS4000 REF 470181Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0856-2025 Class II | 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 470172Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0855-2025 Class II | 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 470171Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0854-2025 Class II | 8MM,PROGRASP FORCEPS,IS4000 REF 470093Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0853-2025 Class II | 8MM,CADIERE FORCEPS,IS4000 REF 470049Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |
| Z-0852-2025 Class II | 8MM,DEBAKEY FORCEPS,IS4000 REF 470036Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | Intuitive Surgical, Inc. | 12/19/2024Open, Classified |