510(k) K980302 ยท HIH Hysteroscope (And Accessories)
WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES
| Applicant | Richard Wolf Medical Instruments Corp., Vernon Hills IL, US |
| Decision | Substantially Equivalent, Jul 20, 1998 |
| Received | Jan 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980302
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2019 | Richard Wolf Medical Instruments Corp. E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product U Terminated |
HIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.