FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RFG-DGP DISPOSABLE GROUNDING PADS
K Number: K923647
·
Decision Nov 9, 1992
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
8
Applicant Total
56
Review Days
111
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Basic Information
- Device Name
- RFG-DGP DISPOSABLE GROUNDING PADS
- K Number
- K923647
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radionics, Inc.
- Date Received
- July 21, 1992
- Decision Date
- November 9, 1992
- Product Code
- JOT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| JOT | Electrode, Gel, Electrosurgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOT), ordered by most recent decision date.
ULTRASOUND TRANSMISSION GEL
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ULTRASOUND COUPLING GEL
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TRIA-SONIC ULTRA SOUND TRANSMISSION GEL
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STERILE ULTRASOUND TRANSMISSION GEL
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ULTRASONIC TRANSMISSION GEL
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STERILIZED OMNI GEL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |