Data / Medical devices / Brazil / H. Strattner
H. Strattner: FDA-registered device maker in Barueri Sao Paulo, Brazil, 96 510(k) clearances
H. Strattner is registered with the FDA (registration 3014663814) in Barueri Sao Paulo, Brazil. It lists 19 device types. The FDA files 96 510(k) clearances under its listings, the newest dated December 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014663814
- Address
- Tucunare Avenue - 550, 5 Andar - Alphaville, Barueri Sao Paulo, Brazil, 06460-020
- 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 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 |
|---|---|---|---|---|---|---|
| December 2, 2025 | K252069 | da Vinci SP Surgical System (SP1098) | NAY | Substantially Equivalent | 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 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 |
| September 19, 2017 | K171632 | da Vinci Xi Surgical System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 17, 2017 | K170640 | Endoscope Sterilization Tray | KCT | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 11, 2017 | K170645 | da Vinci Xi EndoWrist Instruments and Accessories | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| September 11, 2017 | K170644 | da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 28, 2017 | K171699 | da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System | 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 |
| June 13, 2017 | K170713 | da Vinci Xi Surgical System | 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 |
| January 19, 2017 | K161178 | da Vinci Xi Surgical System | 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 |
| August 7, 2016 | K153276 | da Vinci Xi Surgical System | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| July 11, 2016 | K161271 | da Vinci Xi Surgical System | 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 |
| March 30, 2016 | K152578 | da Vinci Surgical System, Model IS4000 | 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 |
| March 4, 2016 | K152421 | IS4000 Stapler 30 Instrument and Stapler 30 Reloads | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | 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 |
| 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 |
| February 24, 2015 | K142937 | Endoscope Sterilization Tray | KCT | 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 |
| 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 |
| December 3, 2012 | K123463 | INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| October 17, 2012 | K113706 | ENDOWRIST STAPLER SYSTEM | 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 |
| 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 |
| August 26, 2011 | K110451 | ENDOWRIST ONE SUCTION/IRRIGATOR | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 4, 2011 | K101743 | 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319 | NAY | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| February 4, 2011 | K101077 | DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 | GCJ | 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 |
| August 1, 2008 | K073112 | DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 | NVE | Substantially Equivalent | Intuitive Surgical, Inc. | accessdata.fda.gov |
| March 6, 2008 | K080155 | MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM | GCJ | 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 |
| May 18, 2006 | K061260 | INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214 | 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 December 2, 2025. 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.