510(k) K052084 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
ENDO-EASE ENDOSCOPIC OVERTUBE
| Applicant | Spirus Medical, Inc., Ayer MA, US |
| Decision | Substantially Equivalent, Sep 14, 2005 |
| Received | Aug 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052084
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.