DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
FDA 510(k) clearance K053363 · decided 2006-05-30
Clearance details
- K-number
- K053363
- Device name
- DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
- Applicant
- Ad-Tech Medical Instrument Corp
- Decision
- Substantially Equivalent
- Date received
- 2005-12-02
- Decision date
- 2006-05-30
- Days to decision
- 179 days
- Clearance type
- Abbreviated
- Product code
- GYC
- Device class
- 2
- Regulation number
- 882.1310
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Stoughton, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 recall (Z-0892-2013) | Ad-Tech Medical Instrument Corporation | 2013-03-02 |