The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. / Cook Endoscopy with the FDA for 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,.
| Device ID | K172665 |
| 510k 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, |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | Wilson-Cook Medical, Inc. / Cook Endoscopy 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Theresa De Prat |
| Correspondent | Theresa De Prat Wilson-Cook Medical, Inc. / Cook Endoscopy 4900 Bethania Station Road Winston-salem, NC 27105 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-05 |
| Decision Date | 2018-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002573007 | K172665 | 000 |
| 10827002572994 | K172665 | 000 |
| 10827002572987 | K172665 | 000 |