FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
K Number: K070881
·
Decision Sep 26, 2007
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
21
Applicant Total
3
Review Days
180
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Basic Information
- Device Name
- LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
- K Number
- K070881
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sapimed S.P.A.
- Date Received
- March 30, 2007
- Decision Date
- September 26, 2007
- Product Code
- FHN
- 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 |
|---|---|---|---|
| FHN | Ligator, Hemorrhoidal | FDA class 2 | Gastroenterology, Urology |
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