The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Soehendra Stent Retriever.
| Device ID | K161203 |
| 510k Number | K161203 |
| Device Name: | Soehendra Stent Retriever |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION ROAD Winston-salem, NC 27105 |
| Contact | Doris A. Hawks |
| Correspondent | Doris A. Hawks WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION ROAD Winston-salem, NC 27105 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-28 |
| Decision Date | 2016-05-04 |
| Summary: | summary |