The following data is part of a premarket notification filed by Wilson-cook Medical Inc. with the FDA for Echo-3-22: Echotip Ultra And Eusn-1, Eusn-3: Echotip Ultrasound Needle.
| Device ID | K171596 |
| 510k Number | K171596 |
| Device Name: | ECHO-3-22: Echotip Ultra And EUSN-1, EUSN-3: Echotip Ultrasound Needle |
| Classification | Biopsy Needle |
| Applicant | Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-salem, NC 27105 |
| Contact | Tiffanny A. Thomas |
| Correspondent | Tiffanny A. Thomas 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 | 2017-05-31 |
| Decision Date | 2017-08-04 |
| Summary: | summary |