510(k) Report

Devices descending from K811390

411 later devices reach CCS100 Cryosurgical System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+7K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+7K233838Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint…Medtronic, Inc.20240—
+7K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202312—
+7K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical…Medtronic, Inc.20220—
+7K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20216—
+7K202968Da Vinci SP Surgical SystemIntuitive Surgical, Inc.202031
+7K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+7K200081NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20202—
+7K200061HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1…Galil Medical, Inc.20200—
+7K200514Cardioblate Gemini-s Surgical Ablation DeviceMedtronic202011
+7K193232Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with…Covidien, LLC20204—
+7K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical202012—
+7K191526Cardioblate CryoFlex Surgical Ablation SystemMedtronic, Inc.20190—
+7K190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20194—
+7K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30Intuitive Surgical20190—
+7K191601Valleylab FT10 Electrosurgical PlatformCovidien201911
+7K183153Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20199—
+7K183385NanoKnife SystemAngiodynamics201971
+7K190151COBRA Fusion Ablation SystemAtriCure, Inc.20190—
+7K183065Coolrail Linear PenAtriCure, Inc.20182—
+7K181941Swift SystemEmblation, Ltd.20183—
+7K181517Senhance Surgical SystemTransenterix, Inc.201810—
+7K180163TransEnterix Senhance Surgical SystemTransenterix, Inc.201811—
+7K173358ARTAS SystemRestoration Robotics, Inc.20180—
+7K170879IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30…Intuitive Surgical, Inc.20170—
+7K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC20176—
+7K171388EndoWrist Stapler 45 System and Stapler 45 ReloadsIntuitive Surgical, Inc.20171—
+7K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+7K163408Isolator Multifunctional Linear PenAtriCure, Inc.20172—
+7K163105Emprint Ablation SystemCovidien, LLC2016133
+7K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016701
+7K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+7K150705FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic…Minimally Invasive Devices, Inc.20153—
+7K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc.2013103—
+7K130726DA Vinci Single-Site Permanent Cautery HookIntuitive Surgical, Inc.201327
+7K120857Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.20122—
+7K121451Cardioblate Maps Surgical Mapping, Ablation, Pacing , and Sensing DeviceMedtronic, Inc.20120—
+7K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Intuitive Surgical, Inc.2012423
+7K062821U-Clip DeviceMedtronic Neurosurgery20060—
+8K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+8K253846Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…Hangzhou Ruidi Biotechnology, Ltd.20260—
+8K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+8K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+8K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+8K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited20250—
+8K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…AngioDynamics, Inc.20241—
+8K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC20242—
+8K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)Covidien, LLC20240—
+8K231798da Vinci SP Surgical SystemIntuitive Surgical, Inc.202311—
+8K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd.20230—
+8K222388swiftPro SystemEmblation, Ltd.20232—
+8K213943SmartSurgN Visualization SystemSmartsurgn Incorporated20221—
+8K220472NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20221—
+8K212871Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) ElectrodeGalvanize Therapeutics, Inc.20222—
+8K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20222—
+8K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+8K212101da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20212—
+8K201265Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd.20214—
+8K211316da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202111
+8K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc.20215—
+8K201262Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd.20214—
+8K211595da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202101
+8K200298ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20212—
+8K203303Emprint SX Ablation Platform with Thermosphere TechnologyCovidien, LLC20200—
+8K200003NP1 Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20201—
+8K200796Emprint Ablation System with Thermosphere TechnologyCovidien, LLC20203—
+8K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20203—
+8K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker20191—
+8K190587Coolrail Linear PenAtriCure, Inc.20191—
+8K191482Senhance Surgical SystemTransenterix, Inc.20198—
+8K183098Senhance Surgical SystemTransenterix, Inc.20180—
+8K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201844—
+8K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker2018331
+8K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+8K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.201668—
+8K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+8K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201636—
+8K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy201476—
+8K142084Epi-Sense Guided Coagulation Device with VisitraxNcontact Surgical, Inc.201411
+8K133203Single-Site PortIntuitive Surgical, Inc.20140—
+9K253994TroKit Laparoscope Lens WiperTroCare, LLC20260—
+9K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.20260—
+9K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20260—
+9K242163SmartSurgN Visualization SystemSmartsurgN, Inc.20260—
+9K260089TL-10 Laparoscopic Scope CleanerScopix, Ltd.20260—
+9K253198NanoKnife Generator (H78720300351US0)Angiodynamics20260—
+9K250786SP Endoscope, 0° (430600)Intuitive Surgical, Inc.20251—
+9K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC20250—
+9K241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.20240—
+9K241825Microwave Ablation AntennasCanyon Medical, Inc.20240—
+9K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—
+9K240502da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20249—
+9K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+9K2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+9K232773da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20240—
+9K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.20240—
+9K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20241—
+9K240518swiftPro™ SystemEmblation Limited20241—
+9K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)Hygea Medical Technology Co., Ltd.20240—