510(k) K062497 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed
REPROCESSED TROCARS
| Applicant | Ascent Healthcare Solutions, Phoenix AZ, US |
| Decision | Substantially Equivalent, Jan 31, 2007 |
| Received | Aug 25, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062497
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2018 | Stryker Sustainability Solutions Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent Terminated |
NLM | None listed |
| Dec 14, 2016 | Stryker Sustainability Solutions Reprocessed Xcel Bladeless Trocar (H12LP)
Model # H12LP
Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally in Terminated |
NLM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.