510(k) K113680 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT
| Applicant | Soma Access Systems, LLC, Greenville SC, US |
| Decision | Substantially Equivalent, Dec 29, 2011 |
| Received | Dec 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113680
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Soma Access Systems LLC AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU).
Sterile Procedure Kit for use AxoTrack enabled Ultra Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.