510(k) clearance
Fule Vertebroplasty Balloon Catheter
- 510(k) number
- K260203
- Applicant
- Beijing Fule Science & Technology Development Co., Ltd.
- Decision date
- Aug 28, 2026
- Date received
- Jan 23, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HRX
- Device type
- Arthroscope
- Device class
- Class II
- Regulation
- 21 CFR 888.1100
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Beijing, CN