FDA 510(k) Applications Submitted by Intuitive Surgical, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K243596 |
11/21/2024 |
da Vinci SP SureForm 45 Staplers and Reloads (SP1098) |
Intuitive Surgical, Inc. |
| K211997 |
06/28/2021 |
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads |
Intuitive Surgical, Inc. |
| K110451 |
02/16/2011 |
ENDOWRIST ONE SUCTION/IRRIGATOR |
INTUITIVE SURGICAL, INC. |
| K110639 |
03/04/2011 |
ENDOWRIST ONE VESSEL SEALER |
INTUITIVE SURGICAL, INC. |
| K161178 |
04/26/2016 |
da Vinci Xi Surgical System |
Intuitive Surgical, Inc. |
| K171294 |
05/02/2017 |
da Vinci X Surgical System |
Intuitive Surgical, Inc. |
| K161271 |
05/05/2016 |
da Vinci Xi Surgical System |
Intuitive Surgical, Inc. |
| K101581 |
06/07/2010 |
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000 |
INTUITIVE SURGICAL, INC. |
| K211784 |
06/09/2021 |
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) |
Intuitive Surgical, Inc. |
| K131861 |
06/24/2013 |
DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES |
INTUITIVE SURGICAL, INC. |
| K151794 |
07/01/2015 |
da Vinci Xi Surgical System |
Intuitive Surgical, Inc. |
| K112208 |
08/01/2011 |
INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES |
INTUITIVE SURGICAL, INC. |
| K112263 |
08/08/2011 |
MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY |
INTUITIVE SURGICAL, INC. |
| K172643 |
09/01/2017 |
da Vinci Xi Surgical System; da Vinci X Surgical System |
Intuitive Surgical, Inc. |
| K152578 |
09/10/2015 |
da Vinci Surgical System, Model IS4000 |
INTUITIVE SURGICAL, INC. |
| K202834 |
09/25/2020 |
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) |
Intuitive Surgical, Inc. |
| K133167 |
10/17/2013 |
MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD |
INTUITIVE SURGICAL, INC. |
| K153276 |
11/12/2015 |
da Vinci Xi Surgical System |
INTUITIVE SURGICAL, INC. |
| K183139 |
11/13/2018 |
Endoscope Sterilization Tray |
Intuitive Surgical, Inc. |
| K173585 |
11/20/2017 |
da Vinci Xi Surgical System, da Vinci X Surgical System |
Intuitive Surgical, Inc. |
| K171426 |
05/15/2017 |
da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree |
Intuitive Surgical, Inc. |
| K251202 |
04/18/2025 |
da Vinci Surgical System (IS5000) |
Intuitive Surgical, Inc. |
| K121921 |
07/02/2012 |
INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS |
INTUITIVE SURGICAL, INC. |
| K123840 |
12/13/2012 |
CONNECT FOR DA VINCI SURGICAL SYSTEM(S) |
INTUITIVE SURGICAL, INC. |
| K170508 |
02/21/2017 |
EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads |
Intuitive Surgical, Inc. |
| K170865 |
03/23/2017 |
EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories |
Intuitive Surgical, Inc. |
| K181395 |
05/29/2018 |
Universal Cannula Seal (5-12 mm) |
Intuitive Surgical, Inc. |
| K123329 |
10/26/2012 |
DA VINVI SURGICAL SYSTEM |
INTUITIVE SURGICAL, INC. |
| K124031 |
12/28/2012 |
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM |
INTUITIVE SURGICAL, INC. |
| K210918 |
03/29/2021 |
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System |
Intuitive Surgical, Inc. |
| K211316 |
04/30/2021 |
da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. |
| K211595 |
05/24/2021 |
da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. |
| K231798 |
06/20/2023 |
da Vinci SP Surgical System |
Intuitive Surgical, Inc. |
| K212101 |
07/06/2021 |
da Vinci SP Firefly Imaging System |
Intuitive Surgical, Inc. |
| K212747 |
08/30/2021 |
Da Vinci SP Surgical System |
Intuitive Surgical, Inc. |
| K202968 |
09/30/2020 |
Da Vinci SP Surgical System |
Intuitive Surgical, Inc. |
| K213710 |
11/24/2021 |
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System |
Intuitive Surgical, Inc. |
| K130266 |
02/04/2013 |
ENDOWRIST ONE VESSEL SEALER |
INTUITIVE SURGICAL, INC. |
| K142683 |
09/19/2014 |
12 mm Endoscopes and Accessories |
INTUITIVE SURGICAL, INC. |
| K173337 |
10/23/2017 |
Intuitive Surgical EndoWrist Vessel Sealer Extend |
Intuitive Surgical, Inc. |
| K123463 |
11/09/2012 |
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS |
INTUITIVE SURGICAL, INC. |
| K021036 |
04/01/2002 |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 |
INTUITIVE SURGICAL, INC. |
| K011002 |
04/03/2001 |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 |
INTUITIVE SURGICAL, INC. |
| K001666 |
05/31/2000 |
MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM |
INTUITIVE SURGICAL, INC. |
| K002489 |
08/10/2000 |
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM |
INTUITIVE SURGICAL, INC. |
| K140553 |
03/04/2014 |
ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS |
INTUITIVE SURGICAL, INC. |
| K171388 |
05/11/2017 |
EndoWrist Stapler 45 System and Stapler 45 Reloads |
Intuitive Surgical, Inc. |
| K143132 |
10/31/2014 |
IS4000 8mm Harmonic ACE Curved Shears |
INTUITIVE SURGICAL, INC. |
| K133203 |
10/17/2013 |
SINGLE-SITE PORT |
INTUITIVE SURGICAL, INC. |
| K202571 |
09/04/2020 |
da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories |
Intuitive Surgical, Inc. |
| K173906 |
12/22/2017 |
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories |
Intuitive Surgical, Inc. |
| K231358 |
05/10/2023 |
Universal Seal (5-12 mm) |
Intuitive Surgical, Inc. |
| K242070 |
07/16/2024 |
Ion Endoluminal System (IF 1000) |
Intuitive Surgical, Inc. |
| K220023 |
01/05/2022 |
8mm Monopolar Curved Scissors |
Intuitive Surgical, Inc. |
| K173415 |
11/01/2017 |
EndoWrist 5mm Thoracic Grasper |
Intuitive Surgical, Inc. |
| K082497 |
08/29/2008 |
INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT |
INTUITIVE SURGICAL, INC. |
| K251213 |
04/18/2025 |
Da Vinci Surgical System (IS5000) |
Intuitive Surgical, Inc. |
| K241284 |
05/07/2024 |
da Vinci Surgical System (IS5000) |
Intuitive Surgical, Inc. |
| K242427 |
08/15/2024 |
da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) |
Intuitive Surgical, Inc. |
| K243641 |
11/26/2024 |
da Vinci Surgical System (IS5000) |
Intuitive Surgical, Inc. |
| K240135 |
01/18/2024 |
IonÖ Endoluminal System (IonÖ Fully Articulating Catheter) (IF1000) |
Intuitive Surgical, Inc. |
| K201146 |
04/29/2020 |
Ion Endoluminal System |
Intuitive Surgical, Inc. |
| K212048 |
06/30/2021 |
Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) |
Intuitive Surgical, Inc. |
| K192367 |
08/30/2019 |
Ion Endoluminal System |
Intuitive Surgical, Inc. |
| K081207 |
04/29/2008 |
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE |
INTUITIVE SURGICAL, INC. |
| K990188 |
01/20/1999 |
INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1 |
INTUITIVE SURGICAL, INC. |
| K220299 |
02/02/2022 |
Ion Endoluminal System (IF1000) |
Intuitive Surgical, Inc. |
| K202370 |
08/19/2020 |
Ion Endoluminal System |
Intuitive Surgical, Inc. |
| K232984 |
09/22/2023 |
Ion Endoluminal System (IF1000) |
Intuitive Surgical, Inc. |
| K080291 |
02/04/2008 |
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER |
INTUITIVE SURGICAL, INC. |
| K101077 |
04/19/2010 |
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 |
INTUITIVE SURGICAL, INC. |
| K081137 |
04/21/2008 |
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 |
INTUITIVE SURGICAL, INC. |
| K101743 |
06/22/2010 |
5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319 |
INTUITIVE SURGICAL, INC. |
| K093217 |
10/13/2009 |
5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) |
INTUITIVE SURGICAL, INC. |
| K120215 |
01/24/2012 |
SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE |
INTUITIVE SURGICAL, INC. |
| K112584 |
09/06/2011 |
5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT |
INTUITIVE SURGICAL, INC. |
| K241638 |
06/07/2024 |
8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads |
Intuitive Surgical, Inc. |
| K170645 |
03/02/2017 |
da Vinci Xi EndoWrist Instruments and Accessories |
Intuitive Surgical, Inc. |
| K170640 |
03/02/2017 |
Endoscope Sterilization Tray |
Intuitive Surgical, Inc. |
| K170641 |
03/02/2017 |
da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes |
Intuitive Surgical, Inc. |
| K170644 |
03/02/2017 |
da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) |
Intuitive Surgical, Inc. |
| K250786 |
03/14/2025 |
SP Endoscope, 0░ (430600) |
Intuitive Surgical, Inc. |
| K170879 |
03/24/2017 |
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories |
Intuitive Surgical, Inc. |
| K180964 |
04/12/2018 |
Endoscope Sterilization Tray |
Intuitive Surgical, Inc. |
| K151450 |
05/29/2015 |
Endoscope Sterilization Tray |
INTUITIVE SURGICAL, INC. |
| K241814 |
06/24/2024 |
da Vinci SP Instruments (SP1098) |
Intuitive Surgical, Inc. |
| K183107 |
11/08/2018 |
Intuitive Surgical Vessel Sealer Extend |
Intuitive Surgical, Inc. |
| K203632 |
12/11/2020 |
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments |
Intuitive Surgical, Inc. |
| K214095 |
12/28/2021 |
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments |
Intuitive Surgical, Inc. |
| K152421 |
08/26/2015 |
IS4000 Stapler 30 Instrument and Stapler 30 Reloads |
INTUITIVE SURGICAL, INC. |
| K143217 |
11/10/2014 |
12 mm & Stapler Bladeless Obturators |
INTUITIVE SURGICAL, INC. |
| K170875 |
03/24/2017 |
da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories |
Intuitive Surgical, Inc. |
| K191043 |
04/19/2019 |
da Vinci Handheld Camera |
Intuitive Surgical, Inc. |
| K243582 |
11/20/2024 |
da Vinci SP Advanced Access Port Kit (432701) |
Intuitive Surgical, Inc. |
| K113706 |
12/16/2011 |
ENDOWRIST STAPLER SYSTEM |
INTUITIVE SURGICAL, INC. |
| K250674 |
03/06/2025 |
Vessel Sealer Curved (480522) |
Intuitive Surgical, Inc. |
| K191280 |
05/13/2019 |
E-100 Electrosurgical Generator, SynchroSeal |
Intuitive Surgical, Inc. |
| K251490 |
05/14/2025 |
8 mm Assist Cannula; 12 mm Assist Cannula |
Intuitive Surgical, Inc. |
| K152448 |
08/27/2015 |
da Vinci Single-Site Instrument and Accessories |
INTUITIVE SURGICAL, INC. |
| K130726 |
03/18/2013 |
DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK |
INTUITIVE SURGICAL, INC. |
| K141077 |
04/25/2014 |
DA VINCI FIREFLY IMAGING SYSTEM |
INTUITIVE SURGICAL, INC. |
| K122532 |
08/20/2012 |
DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES |
INTUITIVE SURGICAL, INC. |
| K232610 |
08/28/2023 |
da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation |
Intuitive Surgical, Inc. |
| K162973 |
10/25/2016 |
EndoWrist Suction Irrigator |
Intuitive Surgical, Inc. |
| K990144 |
01/19/1999 |
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM |
INTUITIVE SURGICAL, INC. |
| K231224 |
04/28/2023 |
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) |
Intuitive Surgical, Inc. |
| K011281 |
04/27/2001 |
INTUITIVE SURGICAL ULTRASONIC SHEARS |
INTUITIVE SURGICAL, INC. |
| K012833 |
08/23/2001 |
INTUITIVE SURGICAL BIPOLAR FORCEPS |
INTUITIVE SURGICAL, INC. |
| K013416 |
10/15/2001 |
INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY |
INTUITIVE SURGICAL, INC. |
| K013952 |
11/30/2001 |
INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM |
INTUITIVE SURGICAL, INC. |
| K965001 |
12/16/1996 |
INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR |
INTUITIVE SURGICAL, INC. |
| K050005 |
01/03/2005 |
INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180 |
INTUITIVE SURGICAL, INC. |
| K080155 |
01/23/2008 |
MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM |
INTUITIVE SURGICAL, INC. |
| K050369 |
02/14/2005 |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 |
INTUITIVE SURGICAL, INC. |
| K050404 |
02/17/2005 |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS |
INTUITIVE SURGICAL, INC. |
| K050802 |
03/30/2005 |
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS |
INTUITIVE SURGICAL, INC. |
| K070947 |
04/04/2007 |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER |
INTUITIVE SURGICAL, INC. |
| K040948 |
04/12/2004 |
INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170 |
INTUITIVE SURGICAL, INC. |
| K061260 |
05/05/2006 |
INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214 |
INTUITIVE SURGICAL, INC. |
| K071405 |
05/21/2007 |
PROBE HOLDER SYSTEM |
INTUITIVE SURGICAL, INC. |
| K072211 |
08/09/2007 |
INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS |
INTUITIVE SURGICAL, INC. |
| K072627 |
09/17/2007 |
INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER |
INTUITIVE SURGICAL, INC. |
| K042855 |
10/15/2004 |
INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT |
INTUITIVE SURGICAL, INC. |
| K063220 |
10/24/2006 |
DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 |
INTUITIVE SURGICAL, INC. |
| K073112 |
11/05/2007 |
DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 |
INTUITIVE SURGICAL, INC. |
| K043153 |
11/15/2004 |
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000 |
INTUITIVE SURGICAL, INC. |
| K060391 |
02/15/2006 |
INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182 |
INTUITIVE SURGICAL, INC. |
| K240852 |
03/28/2024 |
da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) |
Intuitive Surgical, Inc. |
| K131962 |
06/27/2013 |
DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES |
INTUITIVE SURGICAL, INC. |
| K242318 |
08/05/2024 |
da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. |
| K182371 |
08/31/2018 |
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories |
Intuitive Surgical, Inc. |
| K243714 |
12/02/2024 |
da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. |
| K140189 |
01/24/2014 |
ENDOWRIST VESSEL SEALER |
INTUITIVE SURGICAL, INC. |
| K190999 |
04/16/2019 |
SureForm 45 Curved Tip, SureForm 45 Gray Reload |
Intuitive Surgical, Inc. |
| K142937 |
10/09/2014 |
Endoscope Sterilization Tray |
INTUITIVE SURGICAL, INC. |
| K150284 |
02/05/2015 |
IS4000 da Vinci EndoWrist Instruments |
INTUITIVE SURGICAL, INC. |
| K150837 |
03/30/2015 |
IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps |
INTUITIVE SURGICAL, INC. |
| K241360 |
05/14/2024 |
Universal Seal (5-12 mm) |
Intuitive Surgical, Inc. |
| K040237 |
01/30/2004 |
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS |
INTUITIVE SURGICAL, INC. |
| K043288 |
11/29/2004 |
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS |
INTUITIVE SURGICAL, INC. |
| K090993 |
04/07/2009 |
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000 |
INTUITIVE SURGICAL, INC. |
| K022574 |
08/02/2002 |
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200 |
INTUITIVE SURGICAL, INC. |
| K180351 |
02/08/2018 |
EndoWrist Mercury Bipolar Grasper |
Intuitive Surgical, Inc. |
| K162411 |
08/29/2016 |
da Vinci Xi 12 û 8 mm Reducer |
Intuitive Surgical, Inc. |
| K152663 |
09/17/2015 |
Bladeless Optical Obturators |
INTUITIVE SURGICAL, INC. |
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