K242237
- 510(k) number
- K242237
- Device name
- Jewel Soft Tissue Reinforcement Device (102-6005)
- Applicant
- Xiros Limited GB
- Product code
- QUW — Mesh, Surgical, Non-Resorbable, Orthopedics, Reinfor
- Decision date
- 2025-07-15
- Date received
- 2024-07-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K242237.pdf
Official FDA record: K242237
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.