510(k) K040893 ยท FCG Biopsy Needle
EASY CORE BIOPSY SYSTEM
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, May 6, 2004 |
| Received | Apr 6, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040893
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific Easy Core Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-104, REF M0065001040 and M0065001041.
For use to endoscopically or percutaneou Terminated |
FCG | None listed |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific Easy Core Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-105, REF M0065001050 and M0065001051.
For use to endoscopically or percutaneou Terminated |
FCG | None listed |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific Easy Core Biopsy Device, 15 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-106, REF M0065001060 and M0065001061.
For use to endoscopically or percutaneo Terminated |
FCG | None listed |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific Easy Core Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-107, REF M0065001070 and M0065001071.
For use to endoscopically or percutaneous Terminated |
FCG | None listed |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-108, REF M0065001080 and M0065001081.
For use to endoscopically or percutaneousl Terminated |
FCG | None listed |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific TruPath Biopsy Device, 18 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-114, REF M0065001140 and M0065001141.
For use to endoscopically or percutaneousl Terminated |
FCG | None listed |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific TruPath Biopsy Device, 18 ga. x 21 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 500-115, REF M0065001150 and M0065001151.
For use to endoscopically or percutaneousl Terminated |
FCG | None listed |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific Easy Core Biopsy System, 15 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 1213, REF M00512130 and M00512131.
For use to endoscopically or percutaneously ret Terminated |
FCG | None listed |
| Jan 12, 2009 | Boston Scientific Corp Boston Scientific Easy Core Biopsy System, 18 ga. x 15 cm, sterile, latex free. Boston Scientific, Spencer, IN; UPN 1215, REF M00512150 and M00512151.
For use to endoscopically or percutaneously ret Terminated |
FCG | None listed |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-452, UPN MOO1434521, Sterilized with ethylene oxide gas. UPN for inner pouch M001434520.
Indicated for use endoscopically or percut Terminated |
FCG | None listed |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-450, UPN M001434501, Sterilized with ethylene oxide
gas . UPN for inner pouch M001434500
Indicated for use endoscopically or percut Terminated |
FCG | None listed |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-451, UPN M001434511, Sterilized with ethylene oxide gas. UPN for inner pouch M001434510.
Indicated for use endoscopically or percu Terminated |
FCG | None listed |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF 43-453 , M001434531, Sterilized with ethylene oxide gas.
UPN for inner pouch M001434530.
Indicated for use endoscopically or percutan Terminated |
FCG | None listed |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF 43-454, UPN M001434541, Sterilized with ethylene oxide gas. UPN for inner pouch M001434540.
Indicated for use endoscopically or percu Terminated |
FCG | None listed |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-456, UPN M001434561, Sterilized with ethylene oxide gas. UPN for inner pouch M001434560.
Indicated for use endoscopically or percu Terminated |
FCG | None listed |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-457, UPN M001434571, Sterilized with ethylene oxide gas. UPN for inner pouch M001434570.
Indicated for use endoscopically or percu Terminated |
FCG | None listed |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-458, UPN M001434581, Sterilized with ethylene oxide gas. UPN for inner pouch M001434580.
Indicated for use endoscopically or percu Terminated |
FCG | None listed |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF 43-459, UPN M001434591, Sterilized with ethylene oxide gas. UPN for inner pouch M001434590.
Indicated for use endoscopically or percu Terminated |
FCG | None listed |
| Nov 28, 2008 | Boston Scientific Corporation Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF 43-460, UPN M001434601, Sterilized with ethylene oxide gas. UPN for inner pouch M001434600.
M001434601
43-460
Indicated for use endo Terminated |
FCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.