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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K260203
Device Name Fule Vertebroplasty Balloon Catheter
Applicant
Beijing Fule Science & Technology Development Co., Ltd.
#50, Mafang W. Industry Zone, Pinggu District
Beijing,  CN 101204
Applicant Contact Xiaoliang Chen
Correspondent
Beijing Fule Science & Technology Development Co., Ltd.
#50, Mafang W. Industry Zone, Pinggu District
Beijing,  CN 101204
Correspondent Contact Xiaoliang Chen
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
HXG  
Date Received01/23/2026
Decision Date 08/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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