510(k) K150891 ยท FCG Biopsy Needle
BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
| Applicant | Covidien, LLC( Formerly Beacon Endoscopic Corp.), Mansfield MA, US |
| Decision | Substantially Equivalent, May 1, 2015 |
| Received | Apr 2, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150891
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.