Fule Vertebroplasty Balloon Catheter— 510(k) K260203

Name: FDA 510(k) clearance K260203
Creator: U.S. Food and Drug Administration
Published: 2026-08-28

Substantially Equivalent

Beijing 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.

Clearance details

Applicant: Beijing Fule Science & Technology Development Co., Ltd.
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 2026-01-23
Decision date: 2026-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRX

view all

K254103 — HOPKINS Telescopes for Arthroscopy2026-08-26
K252790 — Digital ClarusScope System and Digital NeuroPEN System2026-05-26
K253523 — Freedom DS Decompression System2026-04-16
K252546 — VantageTM Lumbar Decompression Kit2026-03-12
K253217 — MiiS Horus Arthroscope (EJA 100) +2 more2025-12-23

More clearances from Beijing Fule Science & Technology Development Co., Ltd.

view all

K253155 — Fule Metallic Lockable Intramedullary Nail Systems2026-06-17
K253151 — Fule Interbody Fusion Cage System2026-06-15
K252730 — Fule Spinal Fixation System2025-10-24

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.