Ad-Tech Epidural Peg Electrode
FDA 510(k) K912760 · Ad-Tech Medical Instrument Corp
510(k) numberK912760
Submission
- Device name
- Ad-Tech Epidural Peg Electrode
- Applicant
- Ad-Tech Medical Instrument Corp
Racine, WI, US - Received
- June 24, 1991
- Decision date
- January 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K170442 | Cranial Drill Bits and AccessoriesHBE · Traditional | 09/07/2017SE |
| K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…GZL · Traditional | 04/12/2017SE |
| K152769 | Fremap ElectrodeETN · Traditional | 05/06/2016SE |
| K152547 | DNAP ElectrodeGZL · Traditional | 03/04/2016SE |
| K112094 | Brain Biopsy NeedleHAW · Traditional | 04/24/2012SE |
| K053363 | Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes…GYC · Abbreviated | 05/30/2006SE |
Questions and answers
When was Ad-Tech Epidural Peg Electrode cleared by the FDA?
Ad-Tech Epidural Peg Electrode (K912760) received a 510(k) decision of Substantially Equivalent on January 15, 1992, 205 days after the submission was received.
What is the product code of K912760?
The FDA product code is GYC – Electrode, Cortical, a Class II (moderate risk) device regulated under 21 CFR 882.1310.