510(k) K251104 · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
SureTome SW Sphincterotome with DomeTip
| Applicant | Wilson-Cook Medical, Winston-Salem NC, US |
| Decision | Substantially Equivalent, Sep 29, 2025 |
| Received | Apr 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251104
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.