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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K240758
Device Name Radiofrequency Generator System, Cura RF Electrode
Applicant
Zhejiang Curaway Medical Technology Co., Ltd.
Rm. 106, Bldg. 1, # 600, 21st Ave., Baiyang Sub-District, Qi
Hangzhou,  CN 310018
Applicant Contact Ruiran Song
Correspondent
Zhejiang Curaway Medical Technology Co., Ltd.
Rm. 106, Bldg. 1, # 600, 21st Ave.
Baiyang Sub-District, Qiantang New District
Hangzhou,  CN 310000
Correspondent Contact Ruiran Song
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/20/2024
Decision Date 12/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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