The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Direct Peroral Cholangioscopy Balloon.
| Device ID | K101095 |
| 510k Number | K101095 |
| Device Name: | DIRECT PERORAL CHOLANGIOSCOPY BALLOON |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION ROAD Winston Salem, NC |
| Contact | Scottie Fariole |
| Correspondent | Scottie Fariole WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION ROAD Winston Salem, NC |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-20 |
| Decision Date | 2010-07-19 |
| Summary: | summary |