510(k) Report

Devices descending from K060054

14 later devices reach Oncobionic System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080287Oncobionic Bipolar ElectrodeAngioDynamics, Inc.20080—
+1K080202Oncobionic System with 6 Probe OutputOncobionics, Inc.2008111
+1K080376Oncobionic SystemOncobionic Incorporated2008111
+2K102329Nanoknife SystemAngioDynamics, Inc.2011101
+3K240376Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.20240—
+3K150089NanoKnife SystemAngioDynamics, Inc.201581
+4K183385NanoKnife SystemAngiodynamics201971
+5K253846Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…Hangzhou Ruidi Biotechnology, Ltd.20260—
+5K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…AngioDynamics, Inc.20241—
+5K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd.20230—
+5K212871Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) ElectrodeGalvanize Therapeutics, Inc.20222—
+6K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20260—
+6K253198NanoKnife Generator (H78720300351US0)Angiodynamics20260—
+6K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20241—