510(k) K100080 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed
REPROCESSED TROCARS, MODEL B5LT AND CB5LT
| Applicant | Ascent Healthcare Solutions, Phoenix AZ, US |
| Decision | Substantially Equivalent, Mar 19, 2010 |
| Received | Jan 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100080
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2015 | Stryker Sustainability Solutions Stryker
Sustainability Solutions
CB5LT
Ethicon Endo-Surgery, Inc.
Excel Trocar Sleeve
w/Stability Sleeve
5mm x 100mm
Reprocessed by Stryker Sustainability Solutions
Product Usage:
The Reprocessed Eth Terminated |
NLM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.