FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WANDY DISPERSVIE ELECTRODE
K Number: K121268
·
Decision Dec 20, 2012
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
2
Applicant Total
10
Review Days
238
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Basic Information
- Device Name
- WANDY DISPERSVIE ELECTRODE
- K Number
- K121268
- 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
- Bio-Med USA, Inc.
- Date Received
- April 26, 2012
- Decision Date
- December 20, 2012
- Product Code
- ODR
- 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 |
|---|---|---|---|
| ODR | Electrosurgical Patient Return Electrode | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ODR), ordered by most recent decision date.
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SERIES SY DISPOSABLE ELECTROSURGICAL PAD
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FDA Class 2
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