Data / Medical devices / Australia / Device Technologies Australia
Device Technologies Australia: FDA-registered device maker in Marsden Park New South Wales, Australia, 185 510(k) clearances
Device Technologies Australia is registered with the FDA (registration 3010885402) in Marsden Park New South Wales, Australia. It lists 28 device types. The FDA files 185 510(k) clearances under its listings, the newest dated July 14, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010885402
- Address
- 158 Hollinsworth Road, Marsden Park New South Wales, Australia, 2765
- Owner or operator
- Intuitive Surgical, Inc. (9028901)
- Roles
- Exporter to the US
- First device listed
- January 6, 1998
- 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. Newest 100 of 185.
| 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 |
| March 11, 2026 | K253986 | da Vinci Force Feedback Instruments | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 24, 2026 | K253978 | 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 |
| January 16, 2026 | K251739 | da Vinci Surgical System (IS5000) | 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 |
| October 3, 2025 | K251426 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 23, 2025 | K252045 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 10, 2025 | K251817 | 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 23, 2025 | K251213 | 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 13, 2025 | K250674 | Vessel Sealer Curved (480522) | NAY | 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 24, 2025 | K243714 | da Vinci SP Surgical System (SP1098) | 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 26, 2024 | K242318 | da Vinci SP Surgical System (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 18, 2024 | K241814 | da Vinci SP Instruments (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 24, 2024 | K242070 | Ion Endoluminal System (IF 1000) | EOQ | Substantially Equivalent | 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 |
| August 5, 2024 | K241635 | da Vinci E-200 Electrosurgical Generator | GEI | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| August 5, 2024 | K241360 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| August 2, 2024 | K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | GEI | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| July 8, 2024 | K240502 | da Vinci SP Surgical System (SP1098) | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 3, 2024 | K241284 | da Vinci Surgical System (IS5000) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 4, 2024 | K232773 | da Vinci SP Surgical System (SP1098) | 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 |
| April 3, 2024 | K240135 | Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | 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 |
| December 18, 2023 | K232984 | Ion Endoluminal System (IF1000) | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| November 8, 2023 | K231798 | da Vinci SP Surgical System | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 5, 2023 | K231358 | Universal Seal (5-12 mm) | GCJ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 21, 2023 | K231212 | da Vinci E-200 Electrosurgical Generator | GEI | Substantially Equivalent | Intuitive Surgical | 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 |
| April 5, 2023 | K230033 | Da Vinci SP Surgical System (SP1098) | NAY | Unknown | 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 |
| February 23, 2023 | K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source | GCJ | Substantially Equivalent | Schoelly Fiberoptic GmbH | 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 |
| October 20, 2022 | K222827 | da Vinci Firefly Imaging 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 |
| 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 |
| December 10, 2021 | K211997 | 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads | 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 |
| September 29, 2021 | K212747 | Da Vinci SP Surgical System | NAY | Unknown | 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 |
| June 23, 2021 | K211595 | 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 |
| September 28, 2020 | K192717 | da Vinci SP Surgical System | NAY | Unknown | Intuitive Surgical, Inc. | accessdata.fda.gov |
| June 26, 2020 | K201146 | Ion Endoluminal System | EOQ | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| April 29, 2020 | K192803 | da Vinci Xi Surgical System, da Vinci X Surgical System | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| March 31, 2020 | K183086 | da Vinci X and Xi Surgical System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 6, 2020 | K191529 | da Vinci Xi Surgical System, da Vinci X Surgical System | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| November 26, 2019 | K192367 | Ion Endoluminal System | EOQ | 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 |
| 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 22, 2019 | K182643 | IRIS 1.0 System | LLZ | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| February 14, 2019 | K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | EOQ | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| February 1, 2019 | K183139 | Endoscope Sterilization Tray | KCT | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| January 18, 2019 | K183224 | SureForm 45, SureForm 45 Reloads | NAY | Substantially Equivalent | Intuitive Surgical | accessdata.fda.gov |
| December 11, 2018 | K183107 | Intuitive Surgical Vessel Sealer Extend | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| October 24, 2018 | K182140 | da Vinci Xi Surgical System, da Vinci X Surgical System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 28, 2018 | K180964 | 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 |
| July 19, 2018 | K173585 | da Vinci Xi Surgical System, da Vinci X Surgical System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 5, 2018 | K173721 | SureForm 60 and SureForm 60 Reloads | NAY | Substantially Equivalent | Intuitive Surgical | 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 |
| January 31, 2018 | K172643 | da Vinci Xi Surgical System; da Vinci X Surgical System | 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 |
| September 21, 2017 | K170641 | da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Surgical, Computer Controlled Instrument
- All makers of Staple, Implantable
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Instrument, Ultrasonic Surgical
- All makers of System, X-Ray, Angiographic
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.