510(k) K042290 ยท KNW Instrument, Biopsy
VACUUM ASSISTED CORE BIOPSY DEVICE
| Applicant | Suros Surgical Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 6, 2004 |
| Received | Aug 24, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042290
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2010 | Hologic, Inc. Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, Hologic, Inc. 6100 Technology Center Drive Indianapolis, IN.
The handpiece is inserted into the breast to th Terminated |
KNW | None listed |
| Mar 18, 2010 | Hologic, Inc. ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx, Sterile, Suros Surgical Systems, Inc. 6100 Technology Center DR. Indianapolis, IN 46278.
Terminated |
KNW | None listed |
| Nov 7, 2008 | Hologic, Inc. ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile, Hologic, Inc., Indianapolis, IN; Model number ATEC 1212-20.
Intended for partial or complete removal of tissue sampl Terminated |
KNW | None listed |
| Jan 23, 2007 | Suros Surgical Systems Inc. Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile; Part no Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.