510(k) Report

Devices descending from K970496

393 later devices reach Heartport Maze System: Cryoprobe Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+6K183153Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20199—
+6K183385NanoKnife SystemAngiodynamics201971
+6K190151COBRA Fusion Ablation SystemAtriCure, Inc.20190—
+6K183065Coolrail Linear PenAtriCure, Inc.20182—
+6K181941Swift SystemEmblation, Ltd.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—
+6K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC20176—
+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—
+6K163408Isolator Multifunctional Linear PenAtriCure, Inc.20172—
+6K163105Emprint Ablation SystemCovidien, LLC2016133
+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—
+6K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc.2013103—
+6K130726DA Vinci Single-Site Permanent Cautery HookIntuitive Surgical, Inc.201327
+6K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20122—
+6K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+6K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Intuitive Surgical, Inc.2012423
+6K062821U-Clip DeviceMedtronic Neurosurgery20060—
+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—
+7K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited20250—
+7K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…AngioDynamics, Inc.20241—
+7K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC20242—
+7K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+7K231798da Vinci SP Surgical SystemIntuitive Surgical, Inc.202311—
+7K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd.20230—
+7K222388swiftPro SystemEmblation, Ltd.20232—
+7K213943SmartSurgN Visualization SystemSmartsurgn Incorporated20221—
+7K220472NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20221—
+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—
+7K201265Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd.20214—
+7K211316da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202111
+7K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc.20215—
+7K201262Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd.20214—
+7K211595da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202101
+7K200298ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20212—
+7K203303Emprint SX Ablation Platform with Thermosphere TechnologyCovidien, LLC20200—
+7K200003NP1 Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20201—
+7K200796Emprint Ablation System with Thermosphere TechnologyCovidien, LLC20203—
+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—
+7K190587Coolrail Linear PenAtriCure, Inc.20191—
+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
+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—
+7K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+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—
+8K250786SP Endoscope, 0° (430600)Intuitive Surgical, Inc.20251—
+8K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC20250—
+8K241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.20240—
+8K241825Microwave Ablation AntennasCanyon Medical, Inc.20240—
+8K240502da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20249—
+8K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+8K2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+8K232773da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20240—
+8K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.20240—
+8K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20241—
+8K240518swiftPro™ SystemEmblation Limited20241—
+8K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)Hygea Medical Technology Co., Ltd.20240—
+8K232240Microwave Ablation System (BD-GT)Betters (Suzhou) Medical Co., Ltd.20231—
+8K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818…Betters (Suzhou) Medical Co., Ltd.20231—
+8K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+8K223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20231—
+8K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+8K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…Schoelly Fiberoptic GmbH20231—
+8K221861FloNavi Endoscopic Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20232—
+8K221672Creo Electrosurgical System with NP1 InstrumentCreo Medical, Ltd.20230—
+8K221252Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd.20230—
+8K222827da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20220—
+8K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation20220—
+8K212747Da Vinci SP Surgical SystemIntuitive Surgical, Inc.20210—
+8K203550ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20212—
+8K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207—
+8K203199RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single…STERIS Corporation20202—
+8K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker202026—
+8K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+8K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—