FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MR COMPATIBLE LEVEEN NEEDLE ELECTRODE
K Number: K982854
·
Decision Nov 10, 1998
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
12
Review Days
89
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Basic Information
- Device Name
- MR COMPATIBLE LEVEEN NEEDLE ELECTRODE
- K Number
- K982854
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Radiotherapeutics Corp.
- Date Received
- August 13, 1998
- Decision Date
- November 10, 1998
- 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 Radiotherapeutics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K011220 | LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE | Jul 1, 2002 | Substantially Equivalent |
| K012315 | LEVEEN ELECTRODE | Oct 11, 2001 | Substantially Equivalent |
| K000241 | RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR | Apr 14, 2000 | Substantially Equivalent |
| K982556 | LEVEEN NEEDLE ELECTRODE | Apr 6, 2000 | Unknown |
| K000032 | LEVEEN NEEDLE ELECTRODE | Mar 30, 2000 | Substantially Equivalent |
| K981672 | RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR | Jul 17, 1998 | Substantially Equivalent |
| K972441 | RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000 | Sep 4, 1997 | Substantially Equivalent |
| K962313 | MODIFIED LEVEEN NEEDLE ELECTRODE | Sep 11, 1996 | Substantially Equivalent |
| K962386 | SENSOR SHEATH TS1 | Aug 20, 1996 | Substantially Equivalent |
| K955144 | RADIOTHERAPEUTICS RF GENERATOR MODEL RF-1000 | Apr 7, 1996 | Substantially Equivalent |