510(k) K053363 ยท GYC Electrode, Cortical
DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
| Applicant | Ad-Tech Medical Instrument Corp, Stoughton WI, US |
| Decision | Substantially Equivalent, May 30, 2006 |
| Received | Dec 2, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K053363
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2019 | Ad-Tech Medical Instrument Corporation Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes Terminated |
GYC | None listed |
| Mar 2, 2013 | Ad-Tech Medical Instrument Corporation Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation Terminated |
GYC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.