510(k) K133845 ยท GCJ Laparoscope, General & Plastic Surgery
8MM TROCAR KIT
| Applicant | Intuitive Surgical, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 19, 2014 |
| Received | Dec 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133845
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2016 | Intuitive Surgical, Inc. SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each Terminated |
GCY | None listed |
| May 10, 2016 | Cell Marque Corporation SIOOA I (EP I84) Rabbit Monoclonal Antibody;
Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361.
Intended for identifying by light microscopy the presence of associated antigens in s Terminated |
NJT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.