FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RFG-3C PLUS
K Number: K982489
·
Decision Oct 5, 1998
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
36
Applicant Total
56
Review Days
80
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Basic Information
- Device Name
- RFG-3C PLUS
- K Number
- K982489
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Radionics, Inc.
- Date Received
- July 17, 1998
- Decision Date
- October 5, 1998
- Product Code
- GXD
- 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 |
|---|---|---|---|
| GXD | Generator, Lesion, Radiofrequency | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXD), ordered by most recent decision date.
GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)
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FDA Class 2
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FDA Class 2
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Racz Neurostat RF Generator
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FDA Class 2
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FDA Class 2
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FDA Class 2
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Abbott Medical Grounding Pad, model RF-DGP-IS
FDA 510(k)
FDA Class 2
·Neurology
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 |