510(k) K920218 ยท ESW Prosthesis, Esophageal
ESOPHAGEAL Z-STENT
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Feb 9, 1994 |
| Received | Jan 16, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920218
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2004 | Wilson-Cook Medical Inc Esophageal Z-Stent Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable Single Use Only, Rx Only, Sterile EO, Wilson-Cook Medical GI Endoscopy, 4900 Bethan Terminated |
ESW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.