Clearance Summary
Fule Vertebroplasty Balloon Catheter received FDA 510(k) clearance under submission number K260203, sponsored by Beijing Fule Science & Technology Development Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-08-28.
- Submission: K260203
- Applicant / Sponsor: Beijing Fule Science & Technology Development Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2026-08-28
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.