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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name focused ultrasound system for non-thermal, mechanical tissue ablation
De Novo Number DEN220087
Device Name Edison System
Requester
histosonics, inc.
16305 36th avenue n
suite 300
plymouth,  MN  55446
Contact daniel kosednar
Regulation Number878.4405
Classification Product Code
QGM  
Date Received12/02/2022
Decision Date 10/06/2023
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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