FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Fibrillar Collagen Wound Dressing
K Number: K213341
·
Decision May 31, 2022
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
47
Review Days
236
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Basic Information
- Device Name
- Fibrillar Collagen Wound Dressing
- K Number
- K213341
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Collagen Matrix, Inc.
- Date Received
- October 7, 2021
- Decision Date
- May 31, 2022
- Product Code
- KGN
- 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 |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | FDA unclassified | Unknown |
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| K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix | Mar 12, 2024 | Substantially Equivalent |
| K231942 | Mineral Collagen Composite Bioactive Extra Moldable | Aug 2, 2023 | Substantially Equivalent |
| K221735 | Mineral Collagen Composite Bioactive Moldable | Dec 20, 2022 | Substantially Equivalent |
| K202183 | Porcine Mineral Collagen Composite | Apr 2, 2021 | Substantially Equivalent |
| K201859 | Porcine Mineral Collagen Composite Moldable | Sep 11, 2020 | Substantially Equivalent |
| K182074 | Mineral Collagen Composite Bioactive Moldable | Mar 21, 2019 | Substantially Equivalent |