510(k) K181811 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
ReTrace Ureteral Access Sheath
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Sep 7, 2018 |
| Received | Jul 6, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181811
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.