510(k) K080095 ยท KNW Instrument, Biopsy
CORAMATE/SPIROTOME SYSTEM
| Applicant | Medinvents, Hasselt, Limburg, BE |
| Decision | Substantially Equivalent, Apr 11, 2008 |
| Received | Jan 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080095
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2014 | Cook Medical Incorporated Spirotome" Soft-Tissue Biopsy Needle Set.
The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle tha Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.