DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES— 510(k) K053363
Substantially EquivalentAd-Tech Medical Instrument Corp
FDA 510(k) clearance K053363 for DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES, Substantially Equivalent on 2006-05-30. Applicant: Ad-Tech Medical Instrument Corp. Device class: 2.
Clearance details
- Applicant
- Ad-Tech Medical Instrument Corp
- Product code
- Code GYC
- Device class
- Class 2
- Regulation
- 21 CFR 882.1310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Stoughton, WI, US
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More clearances from Ad-Tech Medical Instrument Corp
view allRecalls naming K053363
K-number listed on FDA's recall record- Z-2406-2019 — Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
- Z-0892-2013 — 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 of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053363.
Data sourced from openFDA. This site is unofficial and independent of the FDA.