Fule Vertebroplasty Balloon Catheter

FDA 510(k) K260203 · Beijing Fule Science & Technology Development Co., Ltd.

Substantially Equivalent

510(k) numberK260203

Submission

Device name
Fule Vertebroplasty Balloon Catheter
Applicant
Beijing Fule Science & Technology Development Co., Ltd.
Beijing, CN
Received
January 23, 2026
Decision date
August 28, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HRX – Arthroscope
Device class
Class II (moderate risk)
Regulation
21 CFR 888.1100
Specialty
Orthopedic

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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K253523Freedom DS™ Decompression SystemHRX · Traditional Spinal Simplicity04/16/2026SE
K252546VantageTM Lumbar Decompression KitHRX · Traditional Allevion Medical, LLC03/12/2026SE
K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500)…HRX · Traditional Medimaging Integrated Solution, Inc (Miis)12/23/2025SE
K250795Purevue™ FMSHRX · Traditional W.O.M. World of Medicine GmbH12/05/2025SE
K252666Articulator Arthroscopic BurHRX · Traditional Joint Preservation Innovations, LLC11/21/2025SE
K252458Kyphoplasty Balloon Dilatation CathetersHRX · Traditional Shanghai Lange Medtech Co., Ltd.11/03/2025SE
K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHRX · Traditional Hand Biomechanics Lab, Inc.10/15/2025SE
K252594UltraGuideCTR® image guided soft tissue release systemHRX · Traditional Sonex Health09/29/2025SE

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K253155Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional 06/17/2026SE
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K252730Fule Spinal Fixation SystemNKB · Traditional 10/24/2025SE

Questions and answers

When was Fule Vertebroplasty Balloon Catheter cleared by the FDA?

Fule Vertebroplasty Balloon Catheter (K260203) received a 510(k) decision of Substantially Equivalent on August 28, 2026, 217 days after the submission was received.

What is the product code of K260203?

The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.