FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIONICS SINGLE USE GROUND PAD (DGP-HP)
K Number: K030697
·
Decision Apr 4, 2003
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
56
Review Days
29
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Basic Information
- Device Name
- RADIONICS SINGLE USE GROUND PAD (DGP-HP)
- K Number
- K030697
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radionics, Inc.
- Date Received
- March 6, 2003
- Decision Date
- April 4, 2003
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Radionics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K992721 | COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE | Sep 10, 1999 | Substantially Equivalent |