510(k) Report

Devices descending from K003978

413 later devices reach Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K123548The Artas SystemRestoration Robotics, Inc.201314
+5K123154Artas System From Restoration RoboticsRestoration Robotics, Inc.20130—
+5K123840Connect for DA Vinci Surgical System (S)Intuitive Surgical, Inc.20130—
+5K121921Intuitive Surgical Onsite for DA Vinci Surgical SystemsIntuitive Surgical, Inc.20120—
+5K113706Endowrist Stapler SystemIntuitive Surgical, Inc.201221
+5K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.20114312
+5K112072Atricure Cryo Module SystemAtriCure, Inc.201113—
+5K101581Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci Onsite…Intuitive Surgical, Inc.20116—
+5K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20111042
+5K073112DA Vinci Sonicpro Cleaning System, Model 400253Intuitive Surgical, Inc.20085—
+5K062821U-Clip DeviceMedtronic Neurosurgery20060—
+6K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…Medinice S.A.20260—
+6K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+6K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+6K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+6K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+6K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+6K2514908 mm Assist Cannula; 12 mm Assist CannulaIntuitive Surgical, Inc.20250—
+6K242427da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.20250—
+6K2426108mm Monopolar Curved Scissors (470179)Iconocare Health20250—
+6K243582da Vinci SP Advanced Access Port Kit (432701)Intuitive Surgical, Inc.20250—
+6K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+6K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+6K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202312—
+6K220472NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20221—
+6K201265Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd.20214—
+6K201262Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd.20214—
+6K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20216—
+6K200298ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20212—
+6K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…AtriCure, Inc.20202—
+6K202968Da Vinci SP Surgical SystemIntuitive Surgical, Inc.202031
+6K203303Emprint SX Ablation Platform with Thermosphere TechnologyCovidien, LLC20200—
+6K200003NP1 Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20201—
+6K200796Emprint Ablation System with Thermosphere TechnologyCovidien, LLC20203—
+6K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical202012—
+6K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—
+6K190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20194—
+6K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30Intuitive Surgical20190—
+6K183385NanoKnife SystemAngiodynamics201971
+6K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc.20183—
+6K181517Senhance Surgical SystemTransenterix, Inc.201810—
+6K180163TransEnterix Senhance Surgical SystemTransenterix, Inc.201811—
+6K173358ARTAS SystemRestoration Robotics, Inc.20180—
+6K170879IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30…Intuitive Surgical, Inc.20170—
+6K171388EndoWrist Stapler 45 System and Stapler 45 ReloadsIntuitive Surgical, Inc.20171—
+6K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+6K160141miraDry SystemMiramar Labs, Inc.20161—
+6K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016701
+6K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+6K150705FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic…Minimally Invasive Devices, Inc.20153—
+6K133672Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyStryker Sustainability Solutions20140—
+6K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc.2013103—
+6K130726DA Vinci Single-Site Permanent Cautery HookIntuitive Surgical, Inc.201327
+6K121507Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc.201211—
+6K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Intuitive Surgical, Inc.2012423
+7K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+7K253846Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…Hangzhou Ruidi Biotechnology, Ltd.20260—
+7K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+7K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+7K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+7K250371cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc.20250—
+7K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…AngioDynamics, Inc.20241—
+7K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC20242—
+7K241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.20240—
+7K241825Microwave Ablation AntennasCanyon Medical, Inc.20240—
+7K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.20240—
+7K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)Hygea Medical Technology Co., Ltd.20240—
+7K232240Microwave Ablation System (BD-GT)Betters (Suzhou) Medical Co., Ltd.20231—
+7K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818…Betters (Suzhou) Medical Co., Ltd.20231—
+7K231798da Vinci SP Surgical SystemIntuitive Surgical, Inc.202311—
+7K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…AtriCure, Inc.20230—
+7K223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20231—
+7K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd.20230—
+7K221672Creo Electrosurgical System with NP1 InstrumentCreo Medical, Ltd.20230—
+7K213943SmartSurgN Visualization SystemSmartsurgn Incorporated20221—
+7K212871Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) ElectrodeGalvanize Therapeutics, Inc.20222—
+7K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20222—
+7K212101da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20212—
+7K211316da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202111
+7K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc.20215—
+7K211595da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202101
+7K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20203—
+7K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker20191—
+7K191482Senhance Surgical SystemTransenterix, Inc.20198—
+7K183098Senhance Surgical SystemTransenterix, Inc.20180—
+7K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201844—
+7K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker2018331
+7K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+7K180396miraDry SystemMiramar Labs, Inc.20180—
+7K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.201668—
+7K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+7K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201636—
+7K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy201476—
+7K133203Single-Site PortIntuitive Surgical, Inc.20140—
+8K253994TroKit Laparoscope Lens WiperTroCare, LLC20260—
+8K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.20260—
+8K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20260—
+8K242163SmartSurgN Visualization SystemSmartsurgN, Inc.20260—
+8K260089TL-10 Laparoscopic Scope CleanerScopix, Ltd.20260—
+8K253198NanoKnife Generator (H78720300351US0)Angiodynamics20260—