Fule Vertebroplasty Balloon Catheter— 510(k) K260203
Substantially EquivalentBeijing Fule Science & Technology Development Co., Ltd.
FDA 510(k) clearance K260203 for Fule Vertebroplasty Balloon Catheter, Substantially Equivalent on 2026-08-28. Applicant: Beijing Fule Science & Technology Development Co., Ltd.. Device class: 2.
Summary
Beijing Fule Science & Technology Development's Fule Vertebroplasty Balloon Catheter is filed under product code HRX, which the record names as Arthroscope. The record doesn't describe the catheter beyond its name.
Class II, 21 CFR 888.1100. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
The applicant filed from Beijing, China. The substantially equivalent decision came 217 calendar days after receipt (January 23 to August 28, 2026).
Clearance details
- Applicant
- Beijing Fule Science & Technology Development Co., Ltd.
- Product code
- Product code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Recent devices under product code HRX
view allMore clearances from Beijing Fule Science & Technology Development Co., Ltd.
view allAdverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.