510(k) K162973 ยท NAY System, Surgical, Computer Controlled Instrument
EndoWrist Suction Irrigator
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 6, 2017 |
| Received | Oct 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162973
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2018 | Intuitive Surgical, Inc. EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04.
An accessory to the EndoWrist Surgical System, used in endoscopic surgery. Open, Classified |
NAY | None listed |
| Apr 13, 2017 | Intuitive Surgical, Inc. da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument;
PN 480299-03; and
SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440.
General and Plastic Surgery: The EndoWrist Suction Irrigator Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.