FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FORTAFLEX SURGICAL MESH
K Number: K011025
·
Decision Aug 24, 2001
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
12
Review Days
141
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Basic Information
- Device Name
- FORTAFLEX SURGICAL MESH
- K Number
- K011025
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Organogenesis, Inc.
- Date Received
- April 5, 2001
- Decision Date
- August 24, 2001
- Product Code
- FTM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FTM | Mesh, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Organogenesis, Inc.
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|---|---|---|---|
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| K071555 | FORTAGEN ORAL MEMBRANE | Aug 30, 2007 | Substantially Equivalent |
| K051647 | FORTADERM ANTIMICROBIAL WOUND DRESSING | Nov 8, 2005 | Substantially Equivalent |
| K042809 | CUFFPATCH | Nov 2, 2004 | Substantially Equivalent |
| K021107 | FORTAFLEX SURGICAL SLING | May 15, 2002 | Substantially Equivalent |
| K021105 | FORTAFLEX SURGICAL MESH | May 10, 2002 | Substantially Equivalent |
| K020049 | FORTAFLEX SURGICAL MESH | Mar 18, 2002 | Substantially Equivalent |
| K011026 | FORTADERM WOUND DRESSING | Jun 13, 2001 | Substantially Equivalent |
| K011027 | FORTAFLEX SURGICAL SLING | May 30, 2001 | Substantially Equivalent |