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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 K253198
Device Name NanoKnife Generator (H78720300351US0)
Applicant
Angiodynamics
26 Forest St.
Suite 100
Marlborough,  MA  01752
Applicant Contact Brandon Brackett
Correspondent
Angiodynamics
26 Forest St.
Suite 100
Marlborough,  MA  01752
Correspondent Contact Brandon Brackett
Regulation Number878.4400
Classification Product Code
OAB  
Date Received09/26/2025
Decision Date 03/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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