FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
PELVIC FLOOR REPAIR SYSTEM
K Number: K091131
·
Decision May 8, 2009
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
30
Applicant Total
58
Review Days
18
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Basic Information
- Device Name
- PELVIC FLOOR REPAIR SYSTEM
- K Number
- K091131
- 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
- Date Received
- April 20, 2009
- Decision Date
- May 8, 2009
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OTP), ordered by most recent decision date.
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
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AMS ELEVATE PC
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LITE PELVIC FLOOR REPAIR KITS
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EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
FDA 510(k)
FDA Class 3
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SURELIFT PROLAPSE SYSTEM
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
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| K234002 | ICEfx Cryoablation System (FPRCH8000-02) | Mar 13, 2024 | Substantially Equivalent |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | Nov 28, 2023 | Substantially Equivalent |