510(k) K172665 · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and A
| Applicant | Wilson-Cook Medical Inc./Cook Endoscopy, Winston-Salem NC, US |
| Decision | Substantially Equivalent, May 24, 2018 |
| Received | Sep 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172665
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.