FDA.reportPublic FDA data

Device Technologies Australia

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30074870073007487007Device Technologies Australia1N2026-01-0159 Main North Road, Unit 10 Medindie South Australia AU 5081
30101570883010157088Device Technologies Australia1N2026-01-0130 Graystone Street Tingalpa Queensland AU 4173

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2917021649676110K990144INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMNAY2000-07-11
3470361649676110K990144INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMNAY2000-07-11
2917021599223762K253986da Vinci Force Feedback InstrumentsNAY2026-03-11
2917021867016052K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorNAY2026-01-16
2917021854948102K252675da Vinci SP Surgical System (SP1098)NAY2025-12-15
2917022066108222K252528Ion Endoluminal System (IF1000)EOQ2025-09-05
2917021810999774K252350da Vinci SP Firefly Imaging SystemNAY2025-08-28
2917021712454783K252069da Vinci SP Surgical System (SP1098)NAY2025-12-02
3470361712454783K252069da Vinci SP Surgical System (SP1098)NAY2025-12-02
2917021376234761K251763IRISegQIH2025-12-16
2917021078043608K2514908 mm Assist Cannula; 12 mm Assist CannulaGCJ2025-07-02
2917021919202686K251324da Vinci SP Surgical System (SP1098)NAY2025-08-29
2917021303186815K251227da Vinci Surgical System (IS5000)NAY2025-09-08
2917021527576799K251202da Vinci Surgical System (IS5000)NAY2025-07-16
2917021327445930K250786SP Endoscope, 0° (430600)NAY2025-05-13
2917021749021172K250442da Vinci Surgical System, IS5000NAY2025-07-29
2917021734258843K243641da Vinci Surgical System (IS5000)NAY2024-12-16
2917021081307214K243596da Vinci SP SureForm 45 Staplers and Reloads (SP1098)GAG2025-03-10
2917021277276069K243582da Vinci SP Advanced Access Port Kit (432701)NAY2025-02-28
2917021550977271K242461IRISegQIH2024-12-10
2917021943002341K242427da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)NAY2025-04-01
2917021326700674K241913da Vinci Handheld CameraGCJ2024-08-28
2917021936952756K241814da Vinci SP Instruments (SP1098)NAY2024-11-18
2917021756945401K241621Da Vinci Monopolar and Bipolar Adapters (378896)GEI2024-08-02
2917021931159164K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)NAY2025-06-11
2917021163986702K240723da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)NAY2024-05-24
2917021957822816K231358Universal Seal (5-12 mm)GCJ2023-07-05
2917021162486552K231224da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)NAY2023-05-12
2917021960952319K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)NAY2022-11-22
2917021058502531K223039da Vinci E-200 Electrosurgical GeneratorGEI2022-11-28
2917021804001221K220299Ion Endoluminal System (IF1000)EOQ2022-06-16
2917021585445372K2200238mm Monopolar Curved ScissorsNAY2022-01-31
2917021354427278K214095da Vinci X/Xi (IS4200/IS4000) 8mm Reusable InstrumentsNAY2022-08-15
2917021605927517K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemNAY2022-02-17
2917021575409976K212101da Vinci SP Firefly Imaging SystemNAY2021-11-23
2917021291694215K212048Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)EOQ2021-08-26
2917021771776047K211784da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)NAY2021-08-06
2917021917961332K211316da Vinci SP Surgical System (SP1098)NAY2021-07-23
2917021244862964K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemNAY2021-04-26
2917022009541744K203632da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable InstrumentsNAY2021-02-10
2917021998969279K202968Da Vinci SP Surgical SystemNAY2020-12-22
2917021507935828K202834da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)NAY2020-12-10
2917021891963264K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesNAY2020-11-12
2917021198339420K202370Ion Endoluminal SystemEOQ2020-11-16
3470362073620076K201146Ion Endoluminal SystemEOQ2020-06-26
3470361317532513K192803da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2020-04-29
3470361838498386K192367Ion Endoluminal SystemEOQ2019-11-26
3470361807204684K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30NAY2019-07-26
3470361865640334K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2020-02-06
3470361682044864K191280E-100 Electrosurgical Generator, SynchroSealNAY2019-11-14
2917021849454782K191043da Vinci Handheld CameraGCJ2019-06-06
3470361849454782K191043da Vinci Handheld CameraGCJ2019-06-06
2917021318573614K190999SureForm 45 Curved Tip, SureForm 45 Gray ReloadNAY2019-07-12
3470361318573614K190999SureForm 45 Curved Tip, SureForm 45 Gray ReloadNAY2019-07-12
3470361412807843K183224SureForm 45, SureForm 45 ReloadsNAY2019-01-18
2917021327412692K183139Endoscope Sterilization TrayKCT2019-02-01
3470361327412692K183139Endoscope Sterilization TrayKCT2019-02-01
3470361701227604K183107Intuitive Surgical Vessel Sealer ExtendNAY2018-12-11
3470361996153611K183086da Vinci X and Xi Surgical SystemNAY2020-03-31
3470361384052137K182643IRIS 1.0 SystemLLZ2019-02-22
2917021023001908K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY2019-03-14
3470361023001908K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY2019-03-14
3470361353974353K182188Ion Endoluminal System ; Flexision Biopsy NeedleEOQ2019-02-14
3470361245294265K182140da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2018-10-24
2917021652618447K181395Universal Cannula Seal (5-12 mm)GCJ2018-07-27
3470361652618447K181395Universal Cannula Seal (5-12 mm)GCJ2018-07-27
3470361259658604K180964Endoscope Sterilization TrayKCT2018-09-28
2917021509308041K180351EndoWrist Mercury Bipolar GrasperNAY2018-08-07
3470361509308041K180351EndoWrist Mercury Bipolar GrasperNAY2018-08-07
2917022001832704K1800338mm Monopolar Curved ScissorsNAY2018-04-06
3470362001832704K1800338mm Monopolar Curved ScissorsNAY2018-04-06
2917021851755254K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY2018-05-31
3470361851755254K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY2018-05-31
2917022003320174K173842da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2018-04-23
3470361667067088K173721SureForm 60 and SureForm 60 ReloadsNAY2018-07-05
3470361879286938K173585da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2018-07-19
2917021230879251K173415EndoWrist 5mm Thoracic GrasperNAY2018-05-31
3470361230879251K173415EndoWrist 5mm Thoracic GrasperNAY2018-05-31
2917021306520926K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendNAY2018-04-26
3470361306520926K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendNAY2018-04-26
3470361114473670K172643da Vinci Xi Surgical System; da Vinci X Surgical SystemNAY2018-01-31
3470361466225023K171699da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemNAY2017-07-28
3470361951476221K171632da Vinci Xi Surgical SystemNAY2017-09-19
2917021903555570K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeNAY2017-06-13
3470361903555570K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeNAY2017-06-13
2917021991855356K171388EndoWrist Stapler 45 System and Stapler 45 ReloadsNAY2017-05-31
3470361991855356K171388EndoWrist Stapler 45 System and Stapler 45 ReloadsNAY2017-05-31
2917021773635835K171294da Vinci X Surgical SystemNAY2017-05-26
3470361773635835K171294da Vinci X Surgical SystemNAY2017-05-26
3470361500864152K170879IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable AccessoriesNAY2017-09-21
2917021407970436K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and AccessoriesNAY2017-04-21
3470361407970436K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and AccessoriesNAY2017-04-21
3470361297692357K170713da Vinci Xi Surgical SystemNAY2017-06-13
3470361873047453K170645da Vinci Xi EndoWrist Instruments and AccessoriesNAY2017-09-11
3470361298067783K170644da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)NAY2017-09-11
3470361887523700K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesNAY2017-09-21
3470361279671856K170640Endoscope Sterilization TrayKCT2017-09-17
2917021112190839K162973EndoWrist Suction IrrigatorNAY2017-02-06
3470361112190839K162973EndoWrist Suction IrrigatorNAY2017-02-06
3470361148924273K162411da Vinci Xi 12 – 8 mm ReducerNAY2016-09-21
3470362021064938K161271da Vinci Xi Surgical SystemNAY2016-07-11
3470361448867061K161178da Vinci Xi Surgical SystemNAY2017-01-19
3470361192325573K153276da Vinci Xi Surgical SystemNAY2016-08-07
3470361045176031K153126da Vinci Xi Hasson ConeGCJ2015-12-09
2917021704071581K152892da Vinci Xi Surgical SystemNAY2016-04-29
3470361704071581K152892da Vinci Xi Surgical SystemNAY2016-04-29
3470361131717527K152663Bladeless Optical ObturatorsGCJ2015-10-16
3470361902014994K152578da Vinci Surgical System, Model IS4000NAY2016-03-30
3470361566601086K152448da Vinci Single-Site Instrument and AccessoriesNAY2016-03-09
3470361672985548K152421IS4000 Stapler 30 Instrument and Stapler 30 ReloadsNAY2016-03-04
2917021232716681K151794da Vinci Xi Surgical SystemNAY2016-01-15
3470361232716681K151794da Vinci Xi Surgical SystemNAY2016-01-15
2917022001405190K151450Endoscope Sterilization TrayKCT2016-01-12
3470362001405190K151450Endoscope Sterilization TrayKCT2016-01-12
2917021022836725K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsNAY2015-04-29
3470361022836725K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsNAY2015-04-29
2917021941799083K150284IS4000 da Vinci EndoWrist InstrumentsNAY2015-05-15
3470361941799083K150284IS4000 da Vinci EndoWrist InstrumentsNAY2015-05-15
2917021055232770K14321712 mm & Stapler Bladeless ObturatorsNAY2014-12-03
3470361055232770K14321712 mm & Stapler Bladeless ObturatorsNAY2014-12-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NAY1412026-03-11
GCJ142025-07-02
KCT112019-02-01
EOQ72025-09-05
GEI62024-08-02
QIH22025-12-16
LKF22007-10-09
KKX22005-05-17
GAG12025-03-10
LLZ12019-02-22
NVE12008-08-01