FDA 510(k) Applications Submitted by Intuitive Surgical

FDA 510(k) Number Submission Date Device Name Applicant
K191529 06/10/2019 da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical
K133845 12/18/2013 8MM TROCAR KIT INTUITIVE SURGICAL
K133942 12/23/2013 ENDOSCOPE STERILIZATION TRAY INTUITIVE SURGICAL
K182643 09/24/2018 IRIS 1.0 System Intuitive Surgical
K152892 09/30/2015 da Vinci Xi Surgical System INTUITIVE SURGICAL
K192803 09/30/2019 da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical
K141075 04/25/2014 SINGLE-SITE WRISTED NEEDLE DRIVER INTUITIVE SURGICAL
K183224 11/20/2018 SureForm 45, SureForm 45 Reloads Intuitive Surgical
K173721 12/05/2017 SureForm 60 and SureForm 60 Reloads Intuitive Surgical
K182188 08/13/2018 Ion Endoluminal System ; Flexision Biopsy Needle Intuitive Surgical
K231212 04/28/2023 da Vinci E-200 Electrosurgical Generator Intuitive Surgical
K223039 09/29/2022 da Vinci E-200 Electrosurgical Generator Intuitive Surgical
K191736 06/28/2019 da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 Intuitive Surgical


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact