The following data is part of a premarket notification filed by Wilson-cook Medical, Inc./ Cook Endoscopy with the FDA for Fusion Omni Sphincterotome.
| Device ID | K172288 |
| 510k Number | K172288 |
| Device Name: | Fusion OMNI 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 | Sierra Lowe |
| Correspondent | Sierra Lowe 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 | 2017-07-31 |
| Decision Date | 2018-04-17 |
| Summary: | summary |