The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. / Cook Endoscopy with the FDA for Echotip(r) Ultra Fiducial Needle.
| Device ID | K111895 |
| 510k Number | K111895 |
| Device Name: | ECHOTIP(R) ULTRA FIDUCIAL NEEDLE |
| Classification | Marker, Radiographic, Implantable |
| Applicant | WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY 4900 BETHANIA STATION ROAD Winston-salem, NC 27105 |
| Contact | Marge Walls-walker |
| Correspondent | Marge Walls-walker WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY 4900 BETHANIA STATION ROAD Winston-salem, NC 27105 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-05 |
| Decision Date | 2012-04-27 |
| Summary: | summary |