510(k) K170531 ยท EZN Dilator, Catheter, Ureteral
Ureteral Dilators and Percutaneous Nephrostomy Dilators
| Applicant | Coloplast Corp., Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 17, 2017 |
| Received | Feb 22, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170531
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2024 | Coloplast Manufacturing US, LLC Ureteral dilator, REF RBD014 Open, Classified |
EZN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.