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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 K260397
Device Name SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)
Applicant
Hironic Co., Ltd.
19f, U-Tower, 767, Sinsu-Ro
Suji-Gu
Yongin-Si,  KR 16827
Applicant Contact Byoungkook Kim
Correspondent
Hironic Co., Ltd.
19f, U-Tower, 767, Sinsu-Ro
Suji-Gu
Yongin-Si,  KR 16827
Correspondent Contact Byoungkook Kim
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/06/2026
Decision Date 04/06/2026
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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