510(k) Report

Devices descending from K023886

136 later devices reach Erbe Vio Esu with Accessories, Model Vio 300 D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K192867Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)Bovie Medical Corporation Dba Apyx Medical Corporation20191—
+5K191542Apyx Plasma/RF HandpieceBovie Medical Corporation Dba Apyx Medical Corporation20194—
+5K182408Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645Olympus Medical Systems Corp.201913
+5K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces…Bovie Medical Corporation201961
+5K181389Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy PlatformCovidien20185—
+5K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.20180—
+5K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+5K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation20171—
+5K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+6K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+6K253915MOVIVA® Hybrid Ablation ProbeErbe Elektromedizin GmbH20250—
+6K241138ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing…Livsmed, Inc.20241—
+6K242286Superflow Prime Treatment System (ASP-1M)Guangzhou Aimira Innovation Technology Co, Ltd.20240—
+6K233123SilkroHironic Co., Ltd.20241—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K220493Plaxpot Multi PlasmaGcs Co. Limited20230—
+6K223440Plasma Pen (Plasma MD); Plasma Pen (Plasma +)Plasma Concepts20230—
+6K223222Plasma IQNeauvia North America, Inc.20233—
+6K221830Apyx One ConsoleApyx Medical Corporation20220—
+6K220970Renuvion APR HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20223—
+6K211172Single Use Electrosurgical Knife with Fluid Pump SystemMicro-Tech (Nanjing) Co., Ltd.20210—
+6K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation20210—
+6K191484Renuvion/J-Plasma Precise HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation)20190—
+6K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device…Medtronic20182—
+6K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+7K250126ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)Livsmed, Inc.20250—
+7K251334New Doublo 2.0Hironic Co., Ltd.20250—
+7K241099Plasonic (Plasonic)Hironic Co., Ltd.20242—
+7K230272Renuvion® APR HandpieceApyx Medical Corporation20231—
+7K223262Renuvion® APR HandpieceApyx Medical Corporation20232—
+7K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+7K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+8K260397SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)Hironic Co., Ltd.20260—
+8K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+8K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+8K230586Renuvion® Micro HandpieceApyx Medical Corporation20230—