510(k) K052051 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
OMNI SPHINCTEROTOME
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Aug 5, 2005 |
| Received | Jul 29, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052051
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2009 | Cook Endoscopy Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. Terminated |
KNS | None listed |
| Jan 5, 2009 | Cook Endoscopy FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, EC Representative: Cook Ireland Ltd, O'Haioran Road, National Techn Terminated |
KNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.