510(k) K250452 · FED Endoscopic Access Overtube, Gastroenterology-Urology
CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1
| Applicant | MacroLux Medical Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jun 2, 2025 |
| Received | Feb 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250452
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.