510(k) K140553 ยท NAY System, Surgical, Computer Controlled Instrument
ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 25, 2014 |
| Received | Mar 4, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140553
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2021 | Intuitive Surgical, Inc. da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11 Open, Classified |
NAY | None listed |
| Apr 23, 2018 | Intuitive Surgical, Inc. da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model
48645B-03, 12 reloads/box. Terminated |
GDW | None listed |
| Sep 19, 2017 | Intuitive Surgical, Inc. daVinci X EndoWrist(R) Stapler 45, REF 470298
Product Usage:
The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are in Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi English SRK..
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 R Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Danish SRK.
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Rel Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Czech SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloa Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Dutch SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloa Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Finnish SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Rel Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi French SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Relo Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Norwegian SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 R Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi German SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Relo Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Greek SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloa Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Japanese SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Re Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Italian SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Rel Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Korean SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Relo Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Portuguese SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 R Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Swedish SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloa Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Spanish SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Relo Terminated |
NAY | None listed |
| Mar 15, 2017 | Intuitive Surgical, Inc. STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298.
da Vinci Xi Turkish SRK
General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Relo Terminated |
NAY | None listed |
| Aug 26, 2016 | Intuitive Surgical, Inc. STAPLER,IS4000; Model number 470298;
General and Plastic Surgery:
The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with t Terminated |
NAY | None listed |
| Aug 26, 2016 | Intuitive Surgical, Inc. STAPLER 30,IS4000; Model number 470430;
General and Plastic Surgery:
The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci X Terminated |
NAY | None listed |
| Aug 5, 2016 | Intuitive Surgical, Inc. STAPLER 45, IS4000, model number 470298
Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with t Terminated |
NAY | None listed |
| May 27, 2016 | Intuitive Surgical, Inc. SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provi Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.