OAB — Low Energy Direct Current Thermal Ablation System Class II

FDA Device Classification

Classification Details

Product Code
OAB
Device Class
Class II
Regulation Number
878.4400
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

Ablation of soft tissue

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
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K212871galvanize therapeuticsAliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) ElectrodeJune 17, 2022
K183385angiodynamicsNanoKnife SystemJune 18, 2019
K150089angiodynamicsNanoKnife SystemJune 18, 2015
K102329angiodynamicsNANOKNIFE SYSTEMOctober 24, 2011
K080202oncobionicsONCOBIONIC SYSTEM WITH 6 PROBE OUTPUTMay 8, 2008
K080376oncobionic incorporatedONCOBIONIC SYSTEMApril 2, 2008
K060054oncobionicsONCOBIONIC SYSTEMNovember 21, 2006