510(k) K190592 ยท GCJ Laparoscope, General & Plastic Surgery
YelloPort Elite Port Access System
| Applicant | Surgical Innovations Limited, Leeds, GB |
| Decision | Substantially Equivalent, Apr 29, 2019 |
| Received | Mar 7, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190592
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2022 | Surgical Innovations Ltd Product/Part:
YelloPort Elite 12x75 Pencil Point Trocar/ET1207503;
YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures. Open, Classified |
GCJ | None listed |
| Jun 2, 2022 | Surgical Innovations Ltd YelloPort Elite Universal Seal. For use in laparoscopic procedures. Completed |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.