510(k) K103668 ยท FCG Biopsy Needle
BNX FINE NEEDLE ASPIRATION SYSTEM
| Applicant | Boston Endoscopic Engineering, Foster RI, US |
| Decision | Substantially Equivalent, Dec 30, 2010 |
| Received | Dec 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103668
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2017 | Medtronic BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01 Terminated |
FCG | None listed |
| Feb 28, 2017 | Medtronic SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01 Terminated |
FCG | None listed |
| Feb 28, 2017 | Medtronic SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01 Terminated |
FCG | None listed |
| Feb 28, 2017 | Medtronic SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01 Terminated |
FCG | None listed |
| Feb 28, 2017 | Medtronic BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01 Terminated |
FCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.