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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
510(k) Number K241902
Device Name Edison System
Applicant
HistoSonics, Inc.
16305 36th Ave. N. Suite 300
Plymouth,  MN  55446
Applicant Contact LeeAnne Swiridow
Correspondent
HistoSonics, Inc.
16305 36th Ave. N. Suite 300
Plymouth,  MN  55446
Correspondent Contact LeeAnne Swiridow
Classification Product Code
QGM  
Date Received07/01/2024
Decision Date 10/30/2024
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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