FDA 510(k) Applications for Medical Device Product Code "NAY"
(System,Surgical,Computer Controlled Instrument)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K200473 | AKTORmed GmbH | SoloAsisst II, Voice Control | 12/22/2020 |
| K171947 | AKTORmed GmbH | SOLOASSIST II | 09/21/2018 |
| K233866 | Asensus Surgical, Inc. | Senhance Surgical System | 07/19/2024 |
| K211325 | Asensus Surgical, Inc. | Senhance Surgical System | 07/27/2021 |
| K212054 | Asensus Surgical, Inc. | Senhance Surgical System | 08/30/2021 |
| K220889 | Asensus Surgical, Inc. | Senhance Surgical System | 05/27/2022 |
| K223095 | Asensus Surgical, Inc. | Senhance Surgical System | 03/16/2023 |
| K030578 | COMPUTER MOTION, INC. | BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM | 06/24/2003 |
| K021152 | COMPUTER MOTION, INC. | ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES | 09/24/2002 |
| K191736 | Intuitive Surgical | da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 | 07/26/2019 |
| K152892 | INTUITIVE SURGICAL | da Vinci Xi Surgical System | 04/29/2016 |
| K240723 | Intuitive Surgical | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | 05/24/2024 |
| K191529 | Intuitive Surgical | da Vinci Xi Surgical System, da Vinci X Surgical System | 02/06/2020 |
| K192803 | Intuitive Surgical | da Vinci Xi Surgical System, da Vinci X Surgical System | 04/29/2020 |
| K141075 | INTUITIVE SURGICAL | SINGLE-SITE WRISTED NEEDLE DRIVER | 09/26/2014 |
| K183224 | Intuitive Surgical | SureForm 45, SureForm 45 Reloads | 01/18/2019 |
| K173721 | Intuitive Surgical | SureForm 60 and SureForm 60 Reloads | 07/05/2018 |
| K222839 | Intuitive Surgical Inc | EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System | 03/16/2023 |
| K222827 | Intuitive Surgical Inc. | da Vinci Firefly Imaging System | 10/20/2022 |
| K192717 | Intuitive Surgical Inc. | da Vinci SP Surgical System | 09/28/2020 |
| K230033 | Intuitive Surgical Inc. | Da Vinci SP Surgical System (SP1098) | 04/05/2023 |
| K240502 | Intuitive Surgical Inc. | da Vinci SP Surgical System (SP1098) | 07/08/2024 |
| K180033 | Intuitive Surgical, Inc | 8mm Monopolar Curved Scissors | 04/06/2018 |
| K232773 | Intuitive Surgical, Inc | da Vinci SP Surgical System (SP1098) | 06/04/2024 |
| K183086 | Intuitive Surgical, Inc | da Vinci X and Xi Surgical System | 03/31/2020 |
| K223080 | Intuitive Surgical, Inc | da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) | 11/22/2022 |
| K170713 | Intuitive Surgical, Inc | da Vinci Xi Surgical System | 06/13/2017 |
| K171632 | Intuitive Surgical, Inc | da Vinci Xi Surgical System | 09/19/2017 |
| K171699 | Intuitive Surgical, Inc | da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System | 07/28/2017 |
| K173842 | Intuitive Surgical, Inc | da Vinci Xi Surgical System, da Vinci X Surgical System | 04/23/2018 |
| K182140 | Intuitive Surgical, Inc | da Vinci Xi Surgical System, da Vinci X Surgical System | 10/24/2018 |
| K143217 | INTUITIVE SURGICAL, INC. | 12 mm & Stapler Bladeless Obturators | 12/03/2014 |
| K142683 | INTUITIVE SURGICAL, INC. | 12 mm Endoscopes and Accessories | 12/10/2014 |
| K093217 | INTUITIVE SURGICAL, INC. | 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) | 01/21/2010 |
| K101743 | INTUITIVE SURGICAL, INC. | 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319 | 02/04/2011 |
| K112584 | INTUITIVE SURGICAL, INC. | 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT | 09/29/2011 |
| K211997 | Intuitive Surgical, Inc. | 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads | 12/10/2021 |
| K220023 | Intuitive Surgical, Inc. | 8mm Monopolar Curved Scissors | 01/31/2022 |
| K241638 | Intuitive Surgical, Inc. | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads | 09/10/2024 |
| K123840 | INTUITIVE SURGICAL, INC. | CONNECT FOR DA VINCI SURGICAL SYSTEM(S) | 02/14/2013 |
| K141077 | INTUITIVE SURGICAL, INC. | DA VINCI FIREFLY IMAGING SYSTEM | 08/12/2014 |
| K210918 | Intuitive Surgical, Inc. | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | 04/26/2021 |
| K213710 | Intuitive Surgical, Inc. | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | 02/17/2022 |
| K063220 | INTUITIVE SURGICAL, INC. | DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 | 12/01/2006 |
| K203632 | Intuitive Surgical, Inc. | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments | 02/10/2021 |
| K170641 | Intuitive Surgical, Inc. | da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes | 09/21/2017 |
| K170644 | Intuitive Surgical, Inc. | da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) | 09/11/2017 |
| K170875 | Intuitive Surgical, Inc. | da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories | 09/12/2017 |
| K152448 | INTUITIVE SURGICAL, INC. | da Vinci Single-Site Instrument and Accessories | 03/09/2016 |
| K122532 | INTUITIVE SURGICAL, INC. | DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES | 07/30/2013 |
| K130726 | INTUITIVE SURGICAL, INC. | DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK | 06/07/2013 |
| K243582 | Intuitive Surgical, Inc. | da Vinci SP Advanced Access Port Kit (432701) | 02/28/2025 |
| K212101 | Intuitive Surgical, Inc. | da Vinci SP Firefly Imaging System | 11/23/2021 |
| K241814 | Intuitive Surgical, Inc. | da Vinci SP Instruments (SP1098) | 11/18/2024 |
| K202968 | Intuitive Surgical, Inc. | Da Vinci SP Surgical System | 12/22/2020 |
| K212747 | Intuitive Surgical, Inc. | Da Vinci SP Surgical System | 09/29/2021 |
| K231798 | Intuitive Surgical, Inc. | da Vinci SP Surgical System | 11/08/2023 |
| K242318 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098) | 11/26/2024 |
| K243714 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098) | 04/24/2025 |
| K211316 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098) | 07/23/2021 |
| K211595 | Intuitive Surgical, Inc. | da Vinci SP Surgical System (SP1098) | 06/23/2021 |
| K131962 | INTUITIVE SURGICAL, INC. | DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES | 04/17/2014 |
| K173906 | Intuitive Surgical, Inc. | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | 05/31/2018 |
| K182371 | Intuitive Surgical, Inc. | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | 03/14/2019 |
| K202571 | Intuitive Surgical, Inc. | da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories | 11/12/2020 |
| K241284 | Intuitive Surgical, Inc. | da Vinci Surgical System (IS5000) | 07/03/2024 |
| K243641 | Intuitive Surgical, Inc. | da Vinci Surgical System (IS5000) | 12/16/2024 |
| K251202 | Intuitive Surgical, Inc. | da Vinci Surgical System (IS5000) | 07/16/2025 |
| K251213 | Intuitive Surgical, Inc. | Da Vinci Surgical System (IS5000) | 07/23/2025 |
| K232610 | Intuitive Surgical, Inc. | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | 03/14/2024 |
| K131861 | INTUITIVE SURGICAL, INC. | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES | 03/28/2014 |
| K152578 | INTUITIVE SURGICAL, INC. | da Vinci Surgical System, Model IS4000 | 03/30/2016 |
| K171294 | Intuitive Surgical, Inc. | da Vinci X Surgical System | 05/26/2017 |
| K240852 | Intuitive Surgical, Inc. | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) | 06/11/2025 |
| K214095 | Intuitive Surgical, Inc. | da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments | 08/15/2022 |
| K162411 | Intuitive Surgical, Inc. | da Vinci Xi 12 û 8 mm Reducer | 09/21/2016 |
| K171426 | Intuitive Surgical, Inc. | da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree | 06/13/2017 |
| K170645 | Intuitive Surgical, Inc. | da Vinci Xi EndoWrist Instruments and Accessories | 09/11/2017 |
| K151794 | Intuitive Surgical, Inc. | da Vinci Xi Surgical System | 01/15/2016 |
| K153276 | INTUITIVE SURGICAL, INC. | da Vinci Xi Surgical System | 08/07/2016 |
| K161178 | Intuitive Surgical, Inc. | da Vinci Xi Surgical System | 01/19/2017 |
| K161271 | Intuitive Surgical, Inc. | da Vinci Xi Surgical System | 07/11/2016 |
| K202834 | Intuitive Surgical, Inc. | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | 12/10/2020 |
| K211784 | Intuitive Surgical, Inc. | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | 08/06/2021 |
| K231224 | Intuitive Surgical, Inc. | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | 05/12/2023 |
| K242427 | Intuitive Surgical, Inc. | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | 04/01/2025 |
| K173585 | Intuitive Surgical, Inc. | da Vinci Xi Surgical System, da Vinci X Surgical System | 07/19/2018 |
| K172643 | Intuitive Surgical, Inc. | da Vinci Xi Surgical System; da Vinci X Surgical System | 01/31/2018 |
| K123329 | INTUITIVE SURGICAL, INC. | DA VINVI SURGICAL SYSTEM | 09/17/2014 |
| K191280 | Intuitive Surgical, Inc. | E-100 Electrosurgical Generator, SynchroSeal | 11/14/2019 |
| K173415 | Intuitive Surgical, Inc. | EndoWrist 5mm Thoracic Grasper | 05/31/2018 |
| K180351 | Intuitive Surgical, Inc. | EndoWrist Mercury Bipolar Grasper | 08/07/2018 |
| K110451 | INTUITIVE SURGICAL, INC. | ENDOWRIST ONE SUCTION/IRRIGATOR | 08/26/2011 |
| K130266 | INTUITIVE SURGICAL, INC. | ENDOWRIST ONE VESSEL SEALER | 08/29/2013 |
| K110639 | INTUITIVE SURGICAL, INC. | ENDOWRIST ONE VESSEL SEALER | 12/28/2011 |
| K140553 | INTUITIVE SURGICAL, INC. | ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS | 07/25/2014 |
| K170508 | Intuitive Surgical, Inc. | EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads | 03/10/2017 |
| K171388 | Intuitive Surgical, Inc. | EndoWrist Stapler 45 System and Stapler 45 Reloads | 05/31/2017 |
| K113706 | INTUITIVE SURGICAL, INC. | ENDOWRIST STAPLER SYSTEM | 10/17/2012 |
| K162973 | Intuitive Surgical, Inc. | EndoWrist Suction Irrigator | 02/06/2017 |
| K140189 | INTUITIVE SURGICAL, INC. | ENDOWRIST VESSEL SEALER | 06/05/2014 |
| K170865 | Intuitive Surgical, Inc. | EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories | 04/21/2017 |
| K012833 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL BIPOLAR FORCEPS | 11/16/2001 |
| K072627 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER | 02/07/2008 |
| K002489 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM | 03/02/2001 |
| K040237 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS | 07/07/2004 |
| K080291 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER | 03/19/2008 |
| K101581 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000 | 04/08/2011 |
| K081207 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE | 12/19/2008 |
| K123463 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS | 12/03/2012 |
| K081137 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 | 02/18/2009 |
| K070947 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER | 02/14/2008 |
| K043153 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000 | 12/15/2004 |
| K021036 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 | 06/26/2002 |
| K050369 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 | 04/29/2005 |
| K011002 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 | 05/30/2001 |
| K040948 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170 | 05/05/2004 |
| K022574 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200 | 11/12/2002 |
| K090993 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000 | 12/16/2009 |
| K990144 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM | 07/11/2000 |
| K082497 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT | 05/07/2009 |
| K061260 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214 | 05/18/2006 |
| K060391 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182 | 04/10/2006 |
| K173337 | Intuitive Surgical, Inc. | Intuitive Surgical EndoWrist Vessel Sealer Extend | 04/26/2018 |
| K042855 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT | 11/12/2004 |
| K050005 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180 | 01/25/2005 |
| K121921 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS | 10/25/2012 |
| K011281 | INTUITIVE SURGICAL, INC. | INTUITIVE SURGICAL ULTRASONIC SHEARS | 07/24/2001 |
| K183107 | Intuitive Surgical, Inc. | Intuitive Surgical Vessel Sealer Extend | 12/11/2018 |
| K112208 | INTUITIVE SURGICAL, INC. | INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES | 12/08/2011 |
| K143132 | INTUITIVE SURGICAL, INC. | IS4000 8mm Harmonic ACE Curved Shears | 04/02/2015 |
| K150284 | INTUITIVE SURGICAL, INC. | IS4000 da Vinci EndoWrist Instruments | 05/15/2015 |
| K150837 | INTUITIVE SURGICAL, INC. | IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps | 04/29/2015 |
| K152421 | INTUITIVE SURGICAL, INC. | IS4000 Stapler 30 Instrument and Stapler 30 Reloads | 03/04/2016 |
| K170879 | Intuitive Surgical, Inc. | IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories | 09/21/2017 |
| K043288 | INTUITIVE SURGICAL, INC. | MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS | 03/03/2005 |
| K050802 | INTUITIVE SURGICAL, INC. | MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS | 06/29/2005 |
| K112263 | INTUITIVE SURGICAL, INC. | MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY | 10/07/2011 |
| K120215 | INTUITIVE SURGICAL, INC. | SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE | 04/30/2012 |
| K250786 | Intuitive Surgical, Inc. | SP Endoscope, 0░ (430600) | 05/13/2025 |
| K190999 | Intuitive Surgical, Inc. | SureForm 45 Curved Tip, SureForm 45 Gray Reload | 07/12/2019 |
| K250674 | Intuitive Surgical, Inc. | Vessel Sealer Curved (480522) | 06/13/2025 |
| K191482 | TransEnterix Inc. | Senhance Surgical System | 07/11/2019 |
| K171120 | TransEnterix, Inc. | Senhance Surgical Robotic System | 10/13/2017 |
| K181517 | TransEnterix, Inc. | Senhance Surgical System | 10/09/2018 |
| K183098 | TransEnterix, Inc. | Senhance Surgical System | 12/06/2018 |
| K192877 | TransEnterix, Inc. | Senhance Surgical System | 11/22/2019 |
| K202166 | TransEnterix, Inc. | Senhance Surgical System | 03/02/2021 |
| K200049 | TransEnterix, Inc. | Senhance Surgical System | 03/09/2020 |
| K182421 | TransEnterix, Inc. | Senhance Ultrasonic System | 01/11/2019 |
| K180163 | TransEnterix, Inc. | TransEnterix Senhance Surgical System | 05/25/2018 |
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