510(k) K063788 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
| Applicant | Ascent Healthcare Solutions, Phoenix AZ, US |
| Decision | Substantially Equivalent, Oct 15, 2007 |
| Received | Dec 21, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063788
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2015 | Stryker Sustainability Solutions Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73.
Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical pr Terminated |
NLM | None listed |
| Jun 25, 2015 | Stryker Sustainability Solutions Optical Access System; 5mm x 100mm and 12mm x 100mm;
Model #: CTR03 and CTR73.
Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgi Terminated |
NLM | None listed |
| Jun 25, 2015 | Stryker Sustainability Solutions Cannula and Seal; 5mm x 100mm and 12mm x 100mm
Model #: CTS02 and CTS22.
Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical pr Terminated |
NLM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.