FDA 510(k) Applications for Medical Device Product Code "NTB"
(System, Ablation, Ultrasound And Accessories)

FDA 510(k) Number Applicant Device Name Decision Date
K150019 ACOUSTIC MEDSYSTEMS, INC. TheraVision Ultrasound Ablation System and ACOUSTx Applicators 01/13/2016
K022894 EPICOR MEDICAL, INC. EPICOR MEDICAL ABLATION SYSTEM 02/26/2004
K040641 EPICOR MEDICAL, INC. ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1 05/05/2004
K042096 MISONIX, INC. MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM 01/26/2006
K070779 MISONIX, INC. SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM 07/09/2008
K060346 ULTRAZONIX DNT AB ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM 12/22/2006


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