Last synced on 2 December 2022 at 11:04 pm

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172665
510(k) Type
Traditional
Applicant
Wilson-Cook Medical, Inc. / Cook Endoscopy
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/24/2018
Days to Decision
261 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172665
510(k) Type
Traditional
Applicant
Wilson-Cook Medical, Inc. / Cook Endoscopy
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/24/2018
Days to Decision
261 days
Submission Type
Summary