FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K Number: K040558
·
Decision Mar 17, 2004
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
47
Review Days
14
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
- K Number
- K040558
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Collagen Matrix, Inc.
- Date Received
- March 3, 2004
- Decision Date
- March 17, 2004
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGN), ordered by most recent decision date.
ECMT-100 WMD
FDA 510(k)
FDA Unclassified
·Unknown
Catalyze
FDA 510(k)
FDA Unclassified
·Unknown
Roosin Collagen Dressing
FDA 510(k)
FDA Unclassified
·Unknown
Roosin Collagen Powder
FDA 510(k)
FDA Unclassified
·Unknown
MatriDerm
FDA 510(k)
FDA Unclassified
·Unknown
Derma-Gide
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Collagen Matrix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - Repair | Nov 18, 2025 | Substantially Equivalent |
| K243071 | Bovine Dermis Collagen Dermal Matrix | Dec 19, 2024 | Substantially Equivalent |
| K242302 | RejuvaKnee Collagen Meniscus Implant | Oct 2, 2024 | Substantially Equivalent |
| K233203 | Soft Tissue Augmentation Resorbable Matrix | May 1, 2024 | Substantially Equivalent |
| 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 |
| K213341 | Fibrillar Collagen Wound Dressing | May 31, 2022 | Substantially Equivalent |
| K202183 | Porcine Mineral Collagen Composite | Apr 2, 2021 | Substantially Equivalent |
| K201859 | Porcine Mineral Collagen Composite Moldable | Sep 11, 2020 | Substantially Equivalent |