The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter.
| Device ID | K171548 |
| 510k Number | K171548 |
| Device Name: | Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem, NC 57105 |
| Contact | Sierra Lowe |
| Correspondent | Sierra Lowe Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem, NC 57105 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-26 |
| Decision Date | 2017-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002508002 | K171548 | 000 |
| 00827002215719 | K171548 | 000 |
| 00827002215733 | K171548 | 000 |
| 00827002215764 | K171548 | 000 |
| 00827002216136 | K171548 | 000 |
| 00827002217294 | K171548 | 000 |
| 00827002220461 | K171548 | 000 |
| 00827002220614 | K171548 | 000 |
| 00827002220621 | K171548 | 000 |
| 00827002221048 | K171548 | 000 |
| 00827002495715 | K171548 | 000 |
| 00827002495722 | K171548 | 000 |
| 00827002495739 | K171548 | 000 |
| 00827002215689 | K171548 | 000 |