FDA 510(k)
FDA unclassified
Substantially Equivalent
🇮🇸 Iceland
MariGen Wound Extra
K Number: K190528
·
Decision Jul 10, 2019
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
10
Review Days
128
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Basic Information
- Device Name
- MariGen Wound Extra
- K Number
- K190528
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kerecis Limited
- Date Received
- March 4, 2019
- Decision Date
- July 10, 2019
- 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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Other Clearances by Kerecis Limited
| K Number | Device Name | ||
|---|---|---|---|
| K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | Jul 16, 2025 | Substantially Equivalent |
| K251844 | Kerecis SurgiBind (50241) | Jul 15, 2025 | Substantially Equivalent |
| K243843 | Tendon Protect (50242) | Jun 4, 2025 | Substantially Equivalent |
| K241080 | Kerecis Parvus (50207) | Aug 21, 2024 | Substantially Equivalent |
| K213231 | Kerecis Silicone | Jun 29, 2022 | Substantially Equivalent |
| K202430 | Kerecis Reconstruct | May 2, 2021 | Substantially Equivalent |
| K192612 | Kerecis Gingiva Graft | Nov 13, 2020 | Substantially Equivalent |
| K153364 | Kerecis SecureMesh | Aug 19, 2016 | Substantially Equivalent |
| K132343 | MARIGEN WOUND DRESSING | Oct 23, 2013 | Substantially Equivalent |