510(k) K032406 ยท GXI Probe, Radiofrequency Lesion
STRYKER RF ELECTRODES AND CANNULAE
| Applicant | Stryker Instruments, Kalamazoo MI, US |
| Decision | Substantially Equivalent, Apr 1, 2004 |
| Received | Aug 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032406
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2024 | Stryker Corporation This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then ins Open, Classified |
GXI | None listed |
| Aug 2, 2012 | Stryker Instruments Div. of Stryker Corporation RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ( 10/pk)
Product Usage:
The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, a Terminated |
GXI | None listed |
| Aug 2, 2012 | Stryker Instruments Div. of Stryker Corporation RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk)
Product Usage:
The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, Terminated |
GXI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.