FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
K Number: K122459
·
Decision Dec 13, 2012
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
30
Applicant Total
231
Review Days
122
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Basic Information
- Device Name
- PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
- K Number
- K122459
- Device Class
- FDA class 3
- Clearance Type
- Abbreviated
- Regulation Number
- 884.5980
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- August 13, 2012
- Decision Date
- December 13, 2012
- Product Code
- OTP
- Advisory Committee
- Obstetrics/Gynecology
- 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 |
|---|---|---|---|
| OTP | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed | FDA class 3 | Obstetrics/Gynecology |
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