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 |
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 |
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 |
K180033 |
Intuitive Surgical, Inc |
8mm Monopolar Curved Scissors |
04/06/2018 |
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 |
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 |
K212101 |
Intuitive Surgical, Inc. |
da Vinci SP Firefly Imaging System |
11/23/2021 |
K202968 |
Intuitive Surgical, Inc. |
Da Vinci SP Surgical System |
12/22/2020 |
K212747 |
Intuitive Surgical, Inc. |
Da Vinci SP Surgical System |
09/29/2021 |
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 |
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 |
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 |
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 |
K190999 |
Intuitive Surgical, Inc. |
SureForm 45 Curved Tip, SureForm 45 Gray Reload |
07/12/2019 |
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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