FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
K Number: K053361
·
Decision Feb 6, 2006
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
22
Applicant Total
6
Review Days
66
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Basic Information
- Device Name
- MODIFICATION TO: MINIMESH POLYPROPYLENE MESH
- K Number
- K053361
- 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
- Mpathy Medical Devices, Ltd.
- Date Received
- December 2, 2005
- Decision Date
- February 6, 2006
- 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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VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
FDA 510(k)
FDA Class 2
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Other Clearances by Mpathy Medical Devices, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K092203 | OMNISURE URETHRAL SLING, MODEL OTK52 | Aug 12, 2009 | Substantially Equivalent |
| K091180 | MINITAPE URETHRAL SLING | Jul 14, 2009 | Substantially Equivalent |
| K073647 | MINITAPE EXTRA URETHRAL SLING | Mar 3, 2008 | Substantially Equivalent |
| K073646 | MINITAPE URETHRAL SLING | Feb 25, 2008 | Substantially Equivalent |
| K041632 | MINIMESH POLYPROPYLENE MESH | Nov 17, 2004 | Substantially Equivalent |