FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUPRIS RETROPUBIC SLING SYSTEM
K Number: K111233
·
Decision Jun 24, 2011
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
64
Applicant Total
71
Review Days
53
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Basic Information
- Device Name
- SUPRIS RETROPUBIC SLING SYSTEM
- K Number
- K111233
- 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 A/S
- Date Received
- May 2, 2011
- Decision Date
- June 24, 2011
- Product Code
- OTN
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | FDA class 2 | General, Plastic Surgery |
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