FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
SONOPSY
K Number: K013109
·
Decision Mar 12, 2002
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
3
Review Days
176
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Basic Information
- Device Name
- SONOPSY
- K Number
- K013109
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hakko Medical Co., Ltd.
- Date Received
- September 17, 2001
- Decision Date
- March 12, 2002
- Product Code
- FCG
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FCG | Biopsy Needle | FDA class 2 | Gastroenterology, Urology |
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