510(k) K081137 ยท NAY System, Surgical, Computer Controlled Instrument
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 18, 2009 |
| Received | Apr 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081137
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2018 | Intuitive Surgical, Inc. da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units
The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope Terminated |
NAY | None listed |
| Mar 16, 2016 | Intuitive Surgical, Inc. da Vinci S Surgical System (IS4000) user manual English and OUS.
Product Usage:
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assi Terminated |
NAY | None listed |
| Feb 16, 2016 | Intuitive Surgical, Inc. da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The s Terminated |
NAY | None listed |
| Jan 7, 2015 | Intuitive Surgical, Inc. IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000.
Product number 371683-05/Model Number VS3000
The Intuitive Surgical Endoscopic Instrument Control Syste Terminated |
NAY | None listed |
| Jul 4, 2014 | Intuitive Surgical, Inc. Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system.
Intuitive Surgical Inc.
Sunnyvale, CA 94086 Terminated |
NAY | None listed |
| Jul 2, 2014 | Intuitive Surgical, Inc. System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.
Intuitive Surgical Endoscopic Instrument Control System. Terminated |
NAY | None listed |
| Jul 2, 2014 | Intuitive Surgical, Inc. Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.
Intuitive Surgical Endoscopic Instrument Control System. Terminated |
NAY | None listed |
| Jul 2, 2014 | Intuitive Surgical, Inc. Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.
Intuitive Surgical Endoscopic Instrument Control System. Terminated |
NAY | None listed |
| Jul 2, 2014 | Intuitive Surgical, Inc. Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.
Intuitive Surgical Endoscopic Instrument Control System. Terminated |
NAY | None listed |
| Jul 2, 2014 | Intuitive Surgical, Inc. Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.
Intuitive Surgical Endoscopic Instrument Control System. Terminated |
NAY | None listed |
| Jul 2, 2014 | Intuitive Surgical, Inc. Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.
Intuitive Surgical Endoscopic Instrument Control System. Terminated |
NAY | None listed |
| Jul 2, 2014 | Intuitive Surgical, Inc. Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.
Intuitive Surgical Endoscopic Instrument Control System. Terminated |
NAY | None listed |
| Jul 2, 2014 | Intuitive Surgical, Inc. Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.
Intuitive Surgical Endoscopic Instrument Control System. Terminated |
NAY | None listed |
| Jul 2, 2014 | Intuitive Surgical, Inc. IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e.
Intuitive Surgical Endoscopic Instrument Control System. Terminated |
NAY | None listed |
| Jul 2, 2014 | Intuitive Surgical, Inc. Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System .
Intuitive Surgical Endoscopic Instrument Control System. Terminated |
NAY | None listed |
| Jul 2, 2014 | Intuitive Surgical, Inc. Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System .
Intuitive Surgical Endoscopic Instrument Control System. Terminated |
NAY | None listed |
| Jul 2, 2014 | Intuitive Surgical, Inc. Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System .
Intuitive Surgical Endoscopic Instrument Control System. Terminated |
NAY | None listed |
| Dec 3, 2013 | Intuitive Surgical, Inc. Assembly, Patient Side Manipulator on da Vinci Surgical Systems:
da Vinci S Surgical System;
da Vinci SI Surgical System
da Vinci Si-e Surgical System;
Manufactured by Intuitive Surgical
Sunnyvale, C Terminated |
NAY | None listed |
| Nov 4, 2013 | Intuitive Surgical, Inc. Patient Cart used in conjunction with the da Vinci S surgical and SI System.
Intuitive Surgical
1266 Kifer Road
Sunnyvale, CA 94086
The Patient Side Cart (PSC) is a robotic platform used for da Vinc Terminated |
NAY | None listed |
| Nov 4, 2013 | Intuitive Surgical, Inc. da Vinci Vision System Cart, a component of the
da Vinci Si Surgical System IS3000;
Y1903 Illuminator (Illuminator + Lamp Module);
Y1902 Replacement Lamp Modules.
Intuitive Surgical, Sunnyvale, CA.
Terminated |
NAY | None listed |
| Oct 28, 2013 | Intuitive Surgical, Inc. da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer.
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Terminated |
NAY | None listed |
| Jul 11, 2013 | Intuitive Surgical, Inc. da Vinci Si Surgeon Side Cart, model number SS3000;
Manufactured by Intuitive Surgical, Sunnyvale, CA 94086.
Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accu Terminated |
NAY | None listed |
| Jul 11, 2013 | Intuitive Surgical, Inc. da Vinci Si Vision System Cart, model number VS3000;
Manufactured by Intuitive Surgical, Sunnyvale, CA 94086.
Intuitive Surgical endoscopic Instrument Control System is intended to assist in the acc Terminated |
NAY | None listed |
| Apr 13, 2013 | Intuitive Surgical, Inc. IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000.
Arm drapes protect equipment from contamination. Terminated |
NAY | None listed |
| Mar 13, 2012 | Intuitive Surgical, Inc. da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems.
Intuitive Surgical, Inc.
Sunnyvale, CA 94086.
The Intuitive Surgical Endoscopic instrument Control System is intended to Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.