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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 K223135
Device Name AblatePal Radiofrequency Ablation System
Applicant
Compal Electronics, Inc.
# 581, Ruiguang Rd., Neihu District
Taipei City,  TW 11492
Applicant Contact Casper Chen
Correspondent
Compal Electronics, Inc.
# 581, Ruiguang Rd., Neihu District
Taipei City,  TW 11492
Correspondent Contact Casper Chen
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/03/2022
Decision Date 06/30/2023
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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