510(k) Report

Devices descending from K933002

160 later devices reach Erbotom Icc 350 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K222793WavelinQ™ GeneratorC.R. Bard, Inc.20220—
+5K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC20221—
+5K202106Plasmage SystemBrera Medical, Inc.20220—
+5K220071Soniquence Reusable Neutral PlateSoniquence, LLC20220—
+5K211172Single Use Electrosurgical Knife with Fluid Pump SystemMicro-Tech (Nanjing) Co., Ltd.20210—
+5K212643POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America202117
+5K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips…Ellusa, LLC20201—
+5K192813Plasma IQNeauvia North America, Inc.202012—
+5K172757Valleylab FX8 Electrosurgical PlatformCovidien, LLC20176—
+5K170054iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America20170—
+5K171965Resection Electrodes with HF cableOlympus Winter & Ibe GmbH201731
+5K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation2017116
+5K170170Valleylab FT10 Electrosurgical PlatformCovidien, LLC20178—
+5K161600Resection ElectrodesOlympus Winter & Ibe GmbH20160—
+5K153055ACE Electrosurgical Resection and Vaporization Electrodes SeriesAce Medical Devices Pvt., Ltd.20160—
+5K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143—
+5K140189Endowrist Vessel SealerIntuitive Surgical, Inc.201491
+6K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+6K2104788mm Monopolar Curved ScissorsIconocare Health20220—
+6K222425Ellusa Reusable Neutral PlatesEllusa, LLC20220—
+6K210693Plexr PlusGmv S.R.L.20221—
+6K213354Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection…Conmed Corporation20220—
+6K212329Plasma IQNeauvia North America, Inc.20215—
+6K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH202111
+6K210394Electrosurgical accessoryDornier Medtech America, Inc.20210—
+6K201738SubNovii Advanced Plasma TechnologyCartessa Aesthetics20205—
+6K192867Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)Bovie Medical Corporation Dba Apyx Medical Corporation20191—
+6K191542Apyx Plasma/RF HandpieceBovie Medical Corporation Dba Apyx Medical Corporation20194—
+6K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces…Bovie Medical Corporation201961
+6K181389Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy PlatformCovidien20185—
+6K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.20180—
+6K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+6K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation20171—
+6K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+7K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+7K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc.20241—
+7K242286Superflow Prime Treatment System (ASP-1M)Guangzhou Aimira Innovation Technology Co, Ltd.20240—
+7K233123SilkroHironic Co., Ltd.20241—
+7K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+7K220493Plaxpot Multi PlasmaGcs Co. Limited20230—
+7K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc.20230—
+7K223440Plasma Pen (Plasma MD); Plasma Pen (Plasma +)Plasma Concepts20230—
+7K223222Plasma IQNeauvia North America, Inc.20233—
+7K221830Apyx One ConsoleApyx Medical Corporation20220—
+7K220970Renuvion APR HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20223—
+7K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation20210—
+7K191484Renuvion/J-Plasma Precise HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20190—
+7K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+7K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+8K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc.20250—
+8K251334New Doublo 2.0Hironic Co., Ltd.20250—
+8K241099Plasonic (Plasonic)Hironic Co., Ltd.20242—
+8K230272Renuvion® APR HandpieceApyx Medical Corporation20231—
+8K223262Renuvion® APR HandpieceApyx Medical Corporation20232—
+8K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+8K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+9K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd.20260—
+9K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+9K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+9K230586Renuvion® Micro HandpieceApyx Medical Corporation20230—