510(k) K050369 ยท NAY System, Surgical, Computer Controlled Instrument
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 29, 2005 |
| Received | Feb 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050369
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2026 | Intuitive Surgical, Inc. Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument
Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument
Model/Catalog Number: 420179
Software Version: N/A
Product Descript Open, Classified |
NAY | None listed |
| Mar 30, 2026 | Intuitive Surgical, Inc. Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument
Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument
Model/Catalog Number: 420189
Software Version: NA
Product Descriptio Open, Classified |
NAY | None listed |
| Mar 30, 2026 | Intuitive Surgical, Inc. Brand Name: da Vinci S, Si Mega Needle Driver Instrument
Product Name: da Vinci S, Si Mega Needle Driver Instrument
Model/Catalog Number: 420194
Software Version: NA
Product Description: EndoWrist Ins Open, Classified |
NAY | None listed |
| Mar 30, 2026 | Intuitive Surgical, Inc. Brand Name: da Vinci S, Si Grasping Retractor Instrument
Product Name: da Vinci S, Si Grasping Retractor Instrument
Model/Catalog Number: 420278
Software Version: NA
Product Description: EndoWrist Ins Open, Classified |
NAY | None listed |
| Mar 30, 2026 | Intuitive Surgical, Inc. Brand Name: da Vinci S, Si Tenaculum Forceps Instrument
Product Name: da Vinci S, Si Tenaculum Forceps Instrument
Model/Catalog Number: 420207
Software Version: N/A
Product Description: EndoWrist Inst Open, Classified |
NAY | None listed |
| Mar 30, 2026 | Intuitive Surgical, Inc. Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument
Product Name: da Vinci S, Si Permanent Cautery Hook Instrument
Model/Catalog Number: 420183
Software Version: NA
Product Description: EndoW Open, Classified |
NAY | None listed |
| Jul 1, 2022 | Intuitive Surgical, Inc. Da Vinci S/Si Large Clip Applier, Model 420230
Da Vinci S/Si Medium-Large Clip Applier, Model 420327
Da Vinci S/Si Small Clip Applier, Model 420003 Open, Classified |
NAY | None listed |
| Aug 15, 2018 | Intuitive Surgical, Inc. da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16
Product Usage:
EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended f Open, Classified |
NAY | None listed |
| Mar 16, 2016 | Intuitive Surgical, Inc. da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory.
Product Usage:
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate Terminated |
NAY | None listed |
| Jun 17, 2015 | Intuitive Surgical, Inc. Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems.
Intended for endoscopic manipulation of tissue, including grasping. Terminated |
NAY | None listed |
| Jul 8, 2014 | Intuitive Surgical, Inc. Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems
Intuitive Surgical Inc.,
'Sunnyvale, CA 94086 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 16, 2013 | Intuitive Surgical, Inc. Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000.
Manufactured by Intuitive Surgical, Sunnyvale, CA.
EndoWrist Instruments, including scissors, scalpels, forceps, Terminated |
NAY | None listed |
| Dec 16, 2013 | Intuitive Surgical, Inc. Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000.
Manufactured by Intuitive Surgical, Sunnyvale, CA.
EndoWrist Instruments, including scissors, scalpels, forceps, 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 |
| Jun 5, 2013 | Intuitive Surgical, Inc. da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems.
Used to establish a port of entry for Intuitive Surgical EndoWrist instruments, Terminated |
NAY | None listed |
| May 29, 2013 | Intuitive Surgical, Inc. Cannula 8MM Regular.
Provides the means of introduction and placement of an instrument or accessory into the human body. Terminated |
NAY | None listed |
| May 29, 2013 | Intuitive Surgical, Inc. Flush Port (used in almost all da Vinci instruments)
Assists in cleaning the instrument. Terminated |
NAY | None listed |
| May 29, 2013 | Intuitive Surgical, Inc. da Vinci Si Surgeon Console.
Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments. Terminated |
NAY | None listed |
| Apr 13, 2013 | Intuitive Surgical, Inc. IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000.
Arm drapes protect equipment from contamination. Terminated |
NAY | None listed |
| Jul 27, 2012 | Intuitive Surgical, Inc. INSTRUMENT ARM DRAPE IS2000, 20 PACK:
Product Usage:
The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedur Terminated |
NAY | None listed |
| Jul 27, 2012 | Intuitive Surgical, Inc. KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK;
Product Usage:
The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical p Terminated |
NAY | None listed |
| Jul 27, 2012 | Intuitive Surgical, Inc. KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK;
Product Usage:
The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical p Terminated |
NAY | None listed |
| Jul 27, 2012 | Intuitive Surgical, Inc. KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK;
Product Usage:
The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical p Terminated |
NAY | None listed |
| Jul 27, 2012 | Intuitive Surgical, Inc. KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK;
Product Usage:
The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical Terminated |
NAY | None listed |
| Jul 27, 2012 | Intuitive Surgical, Inc. ACCESSORY BASE STARTER KIT,IS3000;
Product Usage:
The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures Terminated |
NAY | None listed |
| Apr 5, 2010 | Intuitive Surgical, Inc. da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7, manufactured by Intuitive Surgical, Sunnyvale, CA. Terminated |
NAY | None listed |
| Sep 16, 2008 | Intuitive Surgical, Inc. da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, manufactured by Intuitive Surgical, Sunnyvale, CA. Terminated |
NAY | None listed |
| Jun 12, 2008 | Intuitive Surgical, Inc. da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Surgical, Inc., Sunnyvale, CA 94086 Terminated |
NAY | None listed |
| Feb 22, 2008 | Intuitive Surgical, Inc. Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS1200 with Isolation Transformer (P/N: 952012) and Vision Cart (Model VS1000), Distributed and Manufactured by: Terminated |
NAY | None listed |
| Feb 22, 2008 | Intuitive Surgical, Inc. Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS2000 with Isolation Transformer (P/N: 952012) and Vision Cart (Model: VS2000), Distributed and Manufactured by Terminated |
NAY | None listed |
| Feb 21, 2008 | Intuitive Surgical, Inc. Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Intuitive Surgical, Sunnyvale, CA 94086. Terminated |
NAY | None listed |
| Jan 31, 2008 | Intuitive Surgical, Inc. da Vinci S Surgical System 8 mm instrument cannula, Part #: 420002-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086 Terminated |
NAY | None listed |
| Jan 31, 2008 | Intuitive Surgical, Inc. da Vinci S Surgical System 8 mm Long instrument cannula, Part #:420004-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086, Terminated |
NAY | None listed |
| Jan 31, 2008 | Intuitive Surgical, Inc. da Vinci S Surgical System 5 mm instrument cannula, Part #: 420011-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086 Terminated |
NAY | None listed |
| Jan 31, 2008 | Intuitive Surgical, Inc. Intuitive brand da Vinci S, 5 mm Instrument Cannula
Model/Part Number: 420011-02, Product is manufactured and distributed by Intuitive Surgical , 950 Kifer Road,
Sunnyvale, CA Terminated |
NAY | None listed |
| Sep 26, 2007 | Intuitive Surgical, Inc. daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system. Terminated |
NAY | None listed |
| Mar 29, 2007 | Intuitive Surgical, Inc. Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm; Distributed and Man Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.