510(k) Report

Devices descending from K973190

122 later devices reach Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K190587Coolrail Linear PenAtriCure, Inc.20191—
+8K162695truFreeze SystemCSA Medical, Inc.20167—
+8K150089NanoKnife SystemAngioDynamics, Inc.201581
+8K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+9K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+9K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—
+9K183385NanoKnife SystemAngiodynamics201971
+9K171522truFreeze Rapid AV Spray KitCSA Medical, Inc.20170—
+9K163244truFreeze SystemCSA Medical, Inc.20175—
+10K253846Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…Hangzhou Ruidi Biotechnology, Ltd.20260—
+10K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…AngioDynamics, Inc.20241—
+10K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—
+10K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd.20230—
+10K212871Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) ElectrodeGalvanize Therapeutics, Inc.20222—
+10K171626truFreeze SystemCSA Medical, Inc.20173—
+10K172041truFreeze SystemCSA Medical, Inc.20170—
+11K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20260—
+11K253198NanoKnife Generator (H78720300351US0)Angiodynamics20260—
+11K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20241—
+11K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20221—
+11K201183Vortex Radial Spray CatheterCSA Medical, Inc.20200—
+12K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20220—