Data / Medical devices / Australia / Device Technologies Australia
Device Technologies Australia: FDA-registered device maker in Tingalpa Queensland, Australia, 92 510(k) clearances
Device Technologies Australia is registered with the FDA (registration 3010157088) in Tingalpa Queensland, Australia. It lists 15 device types. The FDA files 92 510(k) clearances under its listings, the newest dated March 11, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010157088
- Address
- 30 Graystone Street, Tingalpa Queensland, Australia, 4173
- Owner or operator
- Intuitive Surgical, Inc. (9028901)
- Roles
- Exporter to the US
- First device listed
- November 26, 2007
- Registered through
- 2026
- Brand names listed
- 10-12mm+Stapler Cannula Seal, 12 Mm & Stapler Bladeless Obturator, 12 mm Assist Cannula, 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 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 |
|---|---|---|---|---|---|---|
| March 11, 2026 | K253986 | da Vinci Force Feedback Instruments | NAY | 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 |
| December 16, 2025 | K251763 | IRISeg | QIH | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 15, 2025 | K252675 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 2, 2025 | K252069 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 8, 2025 | K251227 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 5, 2025 | K252528 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 29, 2025 | K251324 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 28, 2025 | K252350 | da Vinci SP Firefly Imaging System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 29, 2025 | K250442 | da Vinci Surgical System, IS5000 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 16, 2025 | K251202 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 2, 2025 | K251490 | 8 mm Assist Cannula; 12 mm Assist Cannula | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 11, 2025 | K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 13, 2025 | K250786 | SP Endoscope, 0° (430600) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 1, 2025 | K242427 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 10, 2025 | K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | GAG | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 28, 2025 | K243582 | da Vinci SP Advanced Access Port Kit (432701) | 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 |
| December 10, 2024 | K242461 | IRISeg | QIH | 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 |
| August 28, 2024 | K241913 | da Vinci Handheld Camera | GCJ | Substantially Equivalent | Intuitive Surgical Operations, Inc. | accessdata.fda.gov |
| August 2, 2024 | K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | GEI | Substantially Equivalent | Intuitive Surgical | 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 |
| July 5, 2023 | K231358 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 12, 2023 | K231224 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 28, 2022 | K223039 | da Vinci E-200 Electrosurgical Generator | GEI | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| November 22, 2022 | K223080 | da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) | 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 |
| June 16, 2022 | K220299 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 17, 2022 | K213710 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | 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 |
| August 26, 2021 | K212048 | Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 6, 2021 | K211784 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 23, 2021 | K211316 | da Vinci SP Surgical System (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 26, 2021 | K210918 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 10, 2021 | K203632 | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 22, 2020 | K202968 | Da Vinci SP Surgical System | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 10, 2020 | K202834 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 16, 2020 | K202370 | Ion Endoluminal System | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 12, 2020 | K202571 | da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 12, 2019 | K190999 | SureForm 45 Curved Tip, SureForm 45 Gray Reload | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | 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 |
| August 7, 2018 | K180351 | EndoWrist Mercury Bipolar Grasper | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 27, 2018 | K181395 | Universal Cannula Seal (5-12 mm) | GCJ | 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 23, 2018 | K173842 | da Vinci Xi Surgical System, da Vinci X Surgical System | 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 |
| 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 |
| May 31, 2017 | K171388 | EndoWrist Stapler 45 System and Stapler 45 Reloads | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 26, 2017 | K171294 | da Vinci X Surgical System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 21, 2017 | K170865 | EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories | 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 |
| April 29, 2016 | K152892 | da Vinci Xi Surgical System | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| January 15, 2016 | K151794 | da Vinci Xi Surgical System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| January 12, 2016 | K151450 | Endoscope Sterilization Tray | KCT | 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 |
| December 10, 2014 | K142683 | 12 mm Endoscopes and Accessories | 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 |
| August 1, 2014 | K133942 | ENDOSCOPE STERILIZATION TRAY | KCT | Substantially Equivalent | Intuitive Surgical | 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 |
| 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 |
| December 3, 2012 | K123463 | INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 28, 2011 | K110639 | ENDOWRIST ONE VESSEL SEALER | 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 |
| 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 |
| May 7, 2009 | K082497 | INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT | 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 28, 2008 | K072211 | INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS | KCT | 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 |
| February 7, 2008 | K072627 | INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| October 9, 2007 | K071405 | PROBE HOLDER SYSTEM | LKF | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| December 1, 2006 | K063220 | DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 10, 2006 | K060391 | INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 17, 2005 | K050322 | MICROTEK EQUIPMENT DRAPES | KKX | Substantially Equivalent | Microtek Medical, 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 |
| January 25, 2005 | K050005 | INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 12, 2004 | K042855 | INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| May 5, 2004 | K040948 | INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| January 10, 2002 | K013416 | INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY | GEI | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 16, 2001 | K012833 | INTUITIVE SURGICAL BIPOLAR FORCEPS | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 22, 2001 | K010007 | ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP | GCJ | Substantially Equivalent | Taut, Inc. | accessdata.fda.gov |
| July 11, 2000 | K990144 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
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Updated March 11, 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.