FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UPSYLON Y MESH
K Number: K122794
·
Decision Dec 18, 2012
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
22
Applicant Total
432
Review Days
97
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Basic Information
- Device Name
- UPSYLON Y MESH
- K Number
- K122794
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corp
- Date Received
- September 12, 2012
- Decision Date
- December 18, 2012
- Product Code
- OTO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | FDA class 2 | General, Plastic Surgery |
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