510(k) K062720 ยท FJL Resectoscope
S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES
| Applicant | Richard Wolf Medical Instruments Corp., Vernon Hills IL, US |
| Decision | Substantially Equivalent, Mar 22, 2007 |
| Received | Sep 12, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062720
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2021 | Richard Wolf GmbH CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323 Terminated |
FJL | None listed |
| Nov 4, 2013 | Richard Wolf Medical Instruments Corp. Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/ Terminated |
FJL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.