510(k) K210495 ยท GCJ Laparoscope, General & Plastic Surgery
Port Access System
| Applicant | Surgical Innovations Limited, Leeds, GB |
| Decision | Substantially Equivalent, Jun 18, 2021 |
| Received | Feb 22, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210495
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 17, 2023 | Surgical Innovations Ltd YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR Open, Classified |
GCJ | None listed |
| May 17, 2023 | Surgical Innovations Ltd YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR Open, Classified |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.