FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TYBR Collagen Gel
K Number: K250109
·
Decision Jun 6, 2025
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
13
Applicant Total
1
Review Days
141
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Basic Information
- Device Name
- TYBR Collagen Gel
- K Number
- K250109
- 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
- Tybr Health
- Date Received
- January 16, 2025
- Decision Date
- June 6, 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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