FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX
K Number: K100786
·
Decision Aug 13, 2010
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
67
Applicant Total
3
Review Days
147
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Basic Information
- Device Name
- MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX
- K Number
- K100786
- 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
- Bsd Medical Corp.
- Date Received
- March 19, 2010
- Decision Date
- August 13, 2010
- Product Code
- NEY
- 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 |
|---|---|---|---|
| NEY | System, Ablation, Microwave And Accessories | FDA class 2 | General, Plastic Surgery |
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