FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
FORTADERM ANTIMICROBIAL WOUND DRESSING
K Number: K051647
·
Decision Nov 8, 2005
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
12
Review Days
140
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Basic Information
- Device Name
- FORTADERM ANTIMICROBIAL WOUND DRESSING
- K Number
- K051647
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Organogenesis, Inc.
- Date Received
- June 21, 2005
- Decision Date
- November 8, 2005
- Product Code
- FRO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by Organogenesis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K212579 | FortiShield (Biosynthetic Wound Matrix) | May 2, 2023 | Substantially Equivalent |
| K220317 | PuraPly Micronized Wound Matrix (PuraPly MZ) | Jul 1, 2022 | Substantially Equivalent |
| K071555 | FORTAGEN ORAL MEMBRANE | Aug 30, 2007 | 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 |
| K011025 | FORTAFLEX SURGICAL MESH | Aug 24, 2001 | Substantially Equivalent |
| K011026 | FORTADERM WOUND DRESSING | Jun 13, 2001 | Substantially Equivalent |
| K011027 | FORTAFLEX SURGICAL SLING | May 30, 2001 | Substantially Equivalent |