510(k) K202688 ยท OTJ Laparoscopic Single Port Access Device
AFS Medical Sterile Single-Use Access Port System
| Applicant | Afs Medical Co. , Ltd., Gyeonggi-Do, KR |
| Decision | Substantially Equivalent, Oct 14, 2021 |
| Received | Sep 15, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202688
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.