510(k) K181756 ยท FCG Biopsy Needle
Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
| Applicant | Apriomed AB, Uppsala, SE |
| Decision | Substantially Equivalent, Dec 18, 2018 |
| Received | Jul 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181756
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.