510(k) K211577 ยท GCJ Laparoscope, General & Plastic Surgery
SoftFix Balloon Trocar
| Applicant | Unimax Medical Systems, Inc., New Taipei, TW |
| Decision | Substantially Equivalent, Nov 5, 2021 |
| Received | May 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211577
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.