510(k) K021036 ยท NAY System, Surgical, Computer Controlled Instrument
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 26, 2002 |
| Received | Apr 1, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| 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 |
| Sep 26, 2007 | Intuitive Surgical, Inc. Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Manufactured by Intuitive Surgical, Inc, Sunnyvale, CA 94086 Terminated |
NAY | None listed |
| Apr 22, 2005 | Intuitive Surgical, Inc. Intuiitve Surgical da Vinci 8 mm EndoWrist Curved Scissors, in box. All lots. P/N 400178-01 Terminated |
LRW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.