FDA.reportPublic FDA data

H. Strattner

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146638143014663814H. Strattner1N2026-01-01Tucunare Avenue - 550, 5 Andar - Alphaville Barueri Sao Paulo BR 06460-020

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2788651649676110K990144INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMNAY2000-07-11
2788651712454783K252069da Vinci SP Surgical System (SP1098)NAY2025-12-02
2788652073620076K201146Ion Endoluminal SystemEOQ2020-06-26
2788651317532513K192803da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2020-04-29
2788651838498386K192367Ion Endoluminal SystemEOQ2019-11-26
2788651807204684K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30NAY2019-07-26
2788651865640334K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2020-02-06
2788651682044864K191280E-100 Electrosurgical Generator, SynchroSealNAY2019-11-14
2788651849454782K191043da Vinci Handheld CameraGCJ2019-06-06
2788651318573614K190999SureForm 45 Curved Tip, SureForm 45 Gray ReloadNAY2019-07-12
2788651412807843K183224SureForm 45, SureForm 45 ReloadsNAY2019-01-18
2788651327412692K183139Endoscope Sterilization TrayKCT2019-02-01
2788651701227604K183107Intuitive Surgical Vessel Sealer ExtendNAY2018-12-11
2788651996153611K183086da Vinci X and Xi Surgical SystemNAY2020-03-31
2788651384052137K182643IRIS 1.0 SystemLLZ2019-02-22
2788651023001908K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY2019-03-14
2788651353974353K182188Ion Endoluminal System ; Flexision Biopsy NeedleEOQ2019-02-14
2788651245294265K182140da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2018-10-24
2788651652618447K181395Universal Cannula Seal (5-12 mm)GCJ2018-07-27
2788651259658604K180964Endoscope Sterilization TrayKCT2018-09-28
2788651509308041K180351EndoWrist Mercury Bipolar GrasperNAY2018-08-07
2788652001832704K1800338mm Monopolar Curved ScissorsNAY2018-04-06
2788651851755254K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY2018-05-31
2788651667067088K173721SureForm 60 and SureForm 60 ReloadsNAY2018-07-05
2788651879286938K173585da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY2018-07-19
2788651230879251K173415EndoWrist 5mm Thoracic GrasperNAY2018-05-31
2788651306520926K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendNAY2018-04-26
2788651114473670K172643da Vinci Xi Surgical System; da Vinci X Surgical SystemNAY2018-01-31
2788651466225023K171699da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemNAY2017-07-28
2788651951476221K171632da Vinci Xi Surgical SystemNAY2017-09-19
2788651903555570K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeNAY2017-06-13
2788651991855356K171388EndoWrist Stapler 45 System and Stapler 45 ReloadsNAY2017-05-31
2788651773635835K171294da Vinci X Surgical SystemNAY2017-05-26
2788651500864152K170879IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable AccessoriesNAY2017-09-21
2788651407970436K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and AccessoriesNAY2017-04-21
2788651297692357K170713da Vinci Xi Surgical SystemNAY2017-06-13
2788651873047453K170645da Vinci Xi EndoWrist Instruments and AccessoriesNAY2017-09-11
2788651298067783K170644da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)NAY2017-09-11
2788651887523700K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesNAY2017-09-21
2788651279671856K170640Endoscope Sterilization TrayKCT2017-09-17
2788651112190839K162973EndoWrist Suction IrrigatorNAY2017-02-06
2788651148924273K162411da Vinci Xi 12 – 8 mm ReducerNAY2016-09-21
2788652021064938K161271da Vinci Xi Surgical SystemNAY2016-07-11
2788651448867061K161178da Vinci Xi Surgical SystemNAY2017-01-19
2788651192325573K153276da Vinci Xi Surgical SystemNAY2016-08-07
2788651045176031K153126da Vinci Xi Hasson ConeGCJ2015-12-09
2788651704071581K152892da Vinci Xi Surgical SystemNAY2016-04-29
2788651131717527K152663Bladeless Optical ObturatorsGCJ2015-10-16
2788651902014994K152578da Vinci Surgical System, Model IS4000NAY2016-03-30
2788651566601086K152448da Vinci Single-Site Instrument and AccessoriesNAY2016-03-09
2788651672985548K152421IS4000 Stapler 30 Instrument and Stapler 30 ReloadsNAY2016-03-04
2788651232716681K151794da Vinci Xi Surgical SystemNAY2016-01-15
2788652001405190K151450Endoscope Sterilization TrayKCT2016-01-12
2788651022836725K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsNAY2015-04-29
2788651941799083K150284IS4000 da Vinci EndoWrist InstrumentsNAY2015-05-15
2788651055232770K14321712 mm & Stapler Bladeless ObturatorsNAY2014-12-03
2788651655171763K143132IS4000 8mm Harmonic ACE Curved ShearsNAY2015-04-02
2788651668534900K142937Endoscope Sterilization TrayKCT2015-02-24
2788651695985462K14268312 mm Endoscopes and AccessoriesNAY2014-12-10
2788651797047205K140553ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADSNAY2014-07-25
2788651938095292K140189ENDOWRIST VESSEL SEALERNAY2014-06-05
2788651616657321K133942ENDOSCOPE STERILIZATION TRAYKCT2014-08-01
2788652066551524K1338458MM TROCAR KITGCJ2014-02-19
2788651762280882K133167MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORDGEI2014-01-07
2788651443792233K131861DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESNAY2014-03-28
2788651791132569K130726DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOKNAY2013-06-07
2788651868926009K130266ENDOWRIST ONE VESSEL SEALERNAY2013-08-29
2788651505297784K123463INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALSNAY2012-12-03
2788651252929030K113706ENDOWRIST STAPLER SYSTEMNAY2012-10-17
2788651601899810K1125845MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERTNAY2011-09-29
2788651397979857K112263MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORYNAY2011-10-07
2788651707849165K112208INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIESNAY2011-12-08
2788651643151995K110639ENDOWRIST ONE VESSEL SEALERNAY2011-12-28
2788651114366981K110451ENDOWRIST ONE SUCTION/IRRIGATORNAY2011-08-26
2788651021703102K1017435MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319NAY2011-02-04
2788652014737647K101077DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100GCJ2011-02-04
2788651291271836K0932175 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)NAY2010-01-21
2788651989221702K082497INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENTNAY2009-05-07
2788651349551793K081137INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000NAY2009-02-18
2788651960203829K080155MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEMGCJ2008-03-06
2788651356004576K073112DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253NVE2008-08-01
2788651628016493K072627INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCERNAY2008-02-07
2788651741866341K072211INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYSKCT2008-02-28
2788651778391140K071405PROBE HOLDER SYSTEMLKF2007-10-09
2788651567778987K070947INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPERNAY2008-02-14
2788651572440495K063220DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000NAY2006-12-01
2788651251632096K061260INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214NAY2006-05-18
2788651240858573K060391INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182NAY2006-04-10
2788651737257236K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000NAY2005-04-29
2788651367944853K050322MICROTEK EQUIPMENT DRAPESKKX2005-05-17
2788651628733083K050005INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180NAY2005-01-25
2788651739415148K042855INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENTNAY2004-11-12
2788651666197795K040948INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170NAY2004-05-05
2788651707456219K013416INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILYGEI2002-01-10
2788652052524529K012833INTUITIVE SURGICAL BIPOLAR FORCEPSNAY2001-11-16
2788651176113119K010007ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAPGCJ2001-02-22
2788651057668697
2788651224017324
2788651895476717
2788651922929778

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NAY722025-12-02
GCJ82019-06-06
KCT72019-02-01
EOQ32020-06-26
GEI22014-01-07
LLZ12019-02-22
NVE12008-08-01
LKF12007-10-09
KKX12005-05-17