FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇸 Iceland
Kerecis SecureMesh
K Number: K153364
·
Decision Aug 19, 2016
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
3
Applicant Total
10
Review Days
273
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Basic Information
- Device Name
- Kerecis SecureMesh
- K Number
- K153364
- 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
- Kerecis Limited
- Date Received
- November 20, 2015
- Decision Date
- August 19, 2016
- Product Code
- OXE
- 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 |
|---|---|---|---|
| OXE | Mesh, Surgical, Collagen, Staple Line Reinforcement | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OXE), ordered by most recent decision date.
Biodesign Staple Line Reinforcement
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VERITAS COLLAGEN MATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGISIS STAPLE LINE REINFORCEMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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| 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 |
| K190528 | MariGen Wound Extra | Jul 10, 2019 | Substantially Equivalent |
| K132343 | MARIGEN WOUND DRESSING | Oct 23, 2013 | Substantially Equivalent |