FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Amsel Endo Occluder
K Number: K180650
·
Decision Nov 15, 2018
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
2
Review Days
247
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Basic Information
- Device Name
- Amsel Endo Occluder
- K Number
- K180650
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Amsel Medical Corporation
- Date Received
- March 13, 2018
- Decision Date
- November 15, 2018
- Product Code
- FZP
- 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 |
|---|---|---|---|
| FZP | Clip, Implantable | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Amsel Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K140932 | AMSEL OCCLUDER DEVICE | Jan 23, 2015 | Substantially Equivalent |