K250109
- 510(k) number
- K250109
- Device name
- TYBR Collagen Gel
- Applicant
- Tybr Health TX · US
- Product code
- OWY — Mesh, Surgical, Collagen, Orthopaedics, Reinforcemen
- Decision date
- 2025-06-06
- Date received
- 2025-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K250109.pdf
Official FDA record: K250109
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.