FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESTORELLE M, RESTORELLE XL
K Number: K132061
·
Decision Aug 2, 2013
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
22
Applicant Total
54
Review Days
30
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Basic Information
- Device Name
- RESTORELLE M, RESTORELLE XL
- K Number
- K132061
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coloplast Corp.
- Date Received
- July 3, 2013
- Decision Date
- August 2, 2013
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OTO), ordered by most recent decision date.
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RESTORELLE Y CONTOUR MESH
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VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
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RESTORELLE Y CONTOUR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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