510(k) K133375 ยท GCJ Laparoscope, General & Plastic Surgery
BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR
| Applicant | Banyan Medical, LLC, Warwick RI, US |
| Decision | Substantially Equivalent, Jan 17, 2014 |
| Received | Nov 4, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133375
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2016 | Banyan Medical, LLC Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula.
For Laproscopic Use- Sterile Single Use Only.
Product Code 400-008 Terminated |
GCJ | None listed |
| Sep 7, 2016 | Banyan Medical, LLC Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/
Sideport. Laproscopic Use- Sterile Single Use Only
Product Code 400-009 Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.