FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI
K Number: K961942
·
Decision Aug 18, 1997
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
31
Applicant Total
56
Review Days
455
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Basic Information
- Device Name
- EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI
- K Number
- K961942
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radionics, Inc.
- Date Received
- May 20, 1996
- Decision Date
- August 18, 1997
- Product Code
- GYC
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GYC | Electrode, Cortical | FDA class 2 | Neurology |
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Other Clearances by Radionics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030697 | RADIONICS SINGLE USE GROUND PAD (DGP-HP) | Apr 4, 2003 | Substantially Equivalent |
| K001741 | RADIONICS RF DISC CATHETER ELECTRODE SYSTEM | Oct 23, 2000 | Substantially Equivalent |
| K002773 | NEUROMAP WITH NEURO 100 | Oct 23, 2000 | Substantially Equivalent |
| K992226 | XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM | Aug 4, 2000 | Substantially Equivalent |
| K001950 | OPTICAL TRACKING SYSTEM (OTS) | Jul 26, 2000 | Substantially Equivalent |
| K001700 | XPLAN 2.1 | Jun 28, 2000 | Substantially Equivalent |
| K001431 | MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) | May 17, 2000 | Substantially Equivalent |
| K000057 | RADIONICS LUMBOPERITONEAL SHUNT | Mar 20, 2000 | Substantially Equivalent |
| K993594 | CONFORMAX MMLC VR1 | Dec 15, 1999 | Substantially Equivalent |
| K991399 | RADIONICS MICROELECTRODE KIT | Sep 21, 1999 | Substantially Equivalent |