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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 K243713
Device Name Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)
Applicant
Agnes Medical Co., Ltd.
20, Seohyeon-Ro 210beon-Gil, Bundang-Gu
Seohyeon-Dong, 4, 5f Cocoplaza
Seongnam-Si,  KR 13591
Applicant Contact Heui Kyeong Pak
Correspondent
E & M
D1474, Pyeongcheon Arco Tower, 230, Simin-Daro, Dongan-Gu
Anyangsi,  KR 14067
Correspondent Contact Sanghwa Myung
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/02/2024
Decision Date 08/19/2025
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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