Data / Medical devices / United States / Intuitive Surgical, Inc.
Intuitive Surgical, Inc.: FDA-registered device maker in Peachtree Corners, GA, United States, 52 510(k) clearances
Intuitive Surgical, Inc. is registered with the FDA (registration 3022626486) in Peachtree Corners, GA, United States. It lists 12 device types. The FDA files 52 510(k) clearances under its listings, the newest dated July 14, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3022626486
- Address
- 3795 Data Dr, Peachtree Corners, GA, United States, 30092
- Owner or operator
- Intuitive Surgical, Inc. (9028901)
- Roles
- Manufacturer, Manufacturer for export, Remanufacturer, Repackager or relabeler
- First device listed
- December 7, 2009
- Registered through
- 2027
- Brand names listed
- 10-12mm+Stapler Cannula Seal, 12 Mm & Stapler Bladeless Obturator, 12 mm Blunt Obturator, da Vinci S, Si, 12 mm Endoscope Cannula Mount, APPMED, da Vinci S, Si, 12 mm Endoscope Cannula Mount, Balloon Port, 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci, 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci S, Si, 12 mm Endoscope Cannula Mount, COV and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 14, 2026 | K261249 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| January 16, 2026 | K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 13, 2025 | K250674 | Vessel Sealer Curved (480522) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 16, 2024 | K243641 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 18, 2024 | K241814 | da Vinci SP Instruments (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 10, 2024 | K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 28, 2024 | K241913 | da Vinci Handheld Camera | GCJ | Substantially Equivalent | Intuitive Surgical Operations, Inc. | accessdata.fda.gov |
| July 3, 2024 | K241284 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 24, 2024 | K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| March 14, 2024 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 16, 2023 | K222839 | EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 15, 2022 | K214095 | da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| January 31, 2022 | K220023 | 8mm Monopolar Curved Scissors | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 23, 2021 | K212101 | da Vinci SP Firefly Imaging System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 14, 2019 | K191280 | E-100 Electrosurgical Generator, SynchroSeal | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 26, 2019 | K191736 | da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| June 6, 2019 | K191043 | da Vinci Handheld Camera | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 14, 2019 | K182371 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 1, 2019 | K183139 | Endoscope Sterilization Tray | KCT | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 11, 2018 | K183107 | Intuitive Surgical Vessel Sealer Extend | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 7, 2018 | K180351 | EndoWrist Mercury Bipolar Grasper | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 31, 2018 | K173906 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 31, 2018 | K173415 | EndoWrist 5mm Thoracic Grasper | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 26, 2018 | K173337 | Intuitive Surgical EndoWrist Vessel Sealer Extend | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 6, 2018 | K180033 | 8mm Monopolar Curved Scissors | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 21, 2017 | K170879 | IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 13, 2017 | K171426 | da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 6, 2017 | K162973 | EndoWrist Suction Irrigator | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 21, 2016 | K162411 | da Vinci Xi 12 8 mm Reducer | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 9, 2016 | K152448 | da Vinci Single-Site Instrument and Accessories | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 9, 2015 | K153126 | da Vinci Xi Hasson Cone | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| October 16, 2015 | K152663 | Bladeless Optical Obturators | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 15, 2015 | K150284 | IS4000 da Vinci EndoWrist Instruments | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 29, 2015 | K150837 | IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 2, 2015 | K143132 | IS4000 8mm Harmonic ACE Curved Shears | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 3, 2014 | K143217 | 12 mm & Stapler Bladeless Obturators | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 25, 2014 | K140553 | ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 5, 2014 | K140189 | ENDOWRIST VESSEL SEALER | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 28, 2014 | K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 19, 2014 | K133845 | 8MM TROCAR KIT | GCJ | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| January 7, 2014 | K133167 | MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD | GEI | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 29, 2013 | K130266 | ENDOWRIST ONE VESSEL SEALER | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 7, 2013 | K130726 | DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| October 17, 2012 | K113706 | ENDOWRIST STAPLER SYSTEM | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 8, 2011 | K112208 | INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| October 7, 2011 | K112263 | MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 29, 2011 | K112584 | 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| January 21, 2010 | K093217 | 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 18, 2009 | K081137 | INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 14, 2008 | K070947 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 18, 2006 | K061260 | INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 29, 2005 | K050369 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
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Updated July 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.