510(k) K042457 ยท LJH System, Irrigation, Urological
URO PRO
| Applicant | W.O.M. World of Medicine AG, Hingham MA, US |
| Decision | Substantially Equivalent, Oct 25, 2004 |
| Received | Sep 10, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042457
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2014 | Stryker Endoscopy Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the eva Terminated |
LJH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.