K260203
- 510(k) number
- K260203
- Device name
- Fule Vertebroplasty Balloon Catheter
- Applicant
- Beijing Fule Science & Technology Development Co., Ltd. CN
- Product code
- HRX — Arthroscope
- Decision date
- 2026-08-28
- Date received
- 2026-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K260203.pdf
Official FDA record: K260203
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.