The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Howell Biliary Introducer Needle.
| Device ID | K160890 |
| 510k Number | K160890 |
| Device Name: | Howell Biliary Introducer Needle |
| Classification | Biopsy Needle |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION ROAD Winston-salem, NC 27105 |
| Contact | Ashley Howard |
| Correspondent | Ashley Howard WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION ROAD Winston-salem, NC 27105 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-31 |
| Decision Date | 2017-06-14 |
| Summary: | summary |