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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Energy Direct Current Thermal Ablation System
510(k) Number K253846
Device Name Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02)
Applicant
Hangzhou Ruidi Biotechnology , Ltd.
8/F, 4th Bldg.,#2959 Yuhangtang Rd.,Cangqian St.
Yuhang District,Hangzhou, Zhejiang, 311121, China
Hangzhou,  CN 311121
Applicant Contact Siran Wu
Correspondent
Beijing Tigermed-Jyton Co., Ltd.
Suite 309, 3f, Bldg. 2,Yard # A 10, Shangyuan Rd.
Mentougou District, Beijing, P.R.China
Beijing,  CN 100000
Correspondent Contact Xueping Deng
Regulation Number878.4400
Classification Product Code
OAB  
Date Received12/02/2025
Decision Date 08/12/2026
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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