510(k) K172288 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Fusion OMNI Sphincterotome
| Applicant | Wilson-Cook Medical Inc./Cook Endoscopy, Winston-Salem NC, US |
| Decision | Substantially Equivalent, Apr 17, 2018 |
| Received | Jul 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172288
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.