Wilson-Cook Medical Inc./Cook Endoscopy · Class II · Cleared May 24, 2018
| K-number | K172665 |
| Device name | 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 ACU-1-VL active cords |
| Applicant | Wilson-Cook Medical Inc./Cook Endoscopy |
| Product code | KNS |
| Device class | Class II |
| Decision date | May 24, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 876.4300 |
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