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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Microwave And Accessories
510(k) Number K261636
Device Name Microwave Ablation Antennas
Applicant
Canyon Medical, Inc.
Bldg. 3, Phase 2 Accelerator, #11 Yaogu Ave., Jiangbei New A
Nanjing, Jiangsu Province, People'S Republic Of China
Nanjing,  CN
Applicant Contact Huiqi Jiang
Correspondent
Canyon Medical, Inc.
Bldg. 3, Phase 2 Accelerator, #11 Yaogu Ave., Jiangbei New A
Nanjing, Jiangsu Province, People'S Republic Of China
Nanjing,  CN
Correspondent Contact Huiqi Jiang
Regulation Number878.4400
Classification Product Code
NEY  
Date Received05/18/2026
Decision Date 10/28/2026
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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