510(k) K242173 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
| Applicant | Coloplast Corp., Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 12, 2024 |
| Received | Jul 24, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242173
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.