FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇸 Iceland
Tendon Protect (50242)
K Number: K243843
·
Decision Jun 4, 2025
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
13
Applicant Total
10
Review Days
173
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Basic Information
- Device Name
- Tendon Protect (50242)
- K Number
- K243843
- 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
- December 13, 2024
- Decision Date
- June 4, 2025
- Product Code
- OWY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | FDA class 2 | General, Plastic Surgery |
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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 |
| 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 |
| K153364 | Kerecis SecureMesh | Aug 19, 2016 | Substantially Equivalent |
| K132343 | MARIGEN WOUND DRESSING | Oct 23, 2013 | Substantially Equivalent |