The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Omni Sphincterotome.
| Device ID | K052051 |
| 510k Number | K052051 |
| Device Name: | OMNI SPHINCTEROTOME |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
| Contact | Marge Walls-walker |
| Correspondent | Marge Walls-walker WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-29 |
| Decision Date | 2005-08-05 |
| Summary: | summary |