510(k) Report

Devices descending from K041340

268 later devices reach Guidant Microwave Ablation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242427da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.20250—
+5K2426108mm Monopolar Curved Scissors (470179)Iconocare Health20250—
+5K243582da Vinci SP Advanced Access Port Kit (432701)Intuitive Surgical, Inc.20250—
+5K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+5K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+5K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202312—
+5K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20216—
+5K202968Da Vinci SP Surgical SystemIntuitive Surgical, Inc.202031
+5K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical202012—
+5K190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20194—
+5K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30Intuitive Surgical20190—
+5K183385NanoKnife SystemAngiodynamics201971
+5K181517Senhance Surgical SystemTransenterix, Inc.201810—
+5K180163TransEnterix Senhance Surgical SystemTransenterix, Inc.201811—
+5K173358ARTAS SystemRestoration Robotics, Inc.20180—
+5K170879IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30…Intuitive Surgical, Inc.20170—
+5K171388EndoWrist Stapler 45 System and Stapler 45 ReloadsIntuitive Surgical, Inc.20171—
+5K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+5K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016701
+5K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+5K150705FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic…Minimally Invasive Devices, Inc.20153—
+5K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc.2013103—
+5K130726DA Vinci Single-Site Permanent Cautery HookIntuitive Surgical, Inc.201327
+5K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Intuitive Surgical, Inc.2012423
+6K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+6K253846Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…Hangzhou Ruidi Biotechnology, Ltd.20260—
+6K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+6K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+6K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+6K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…AngioDynamics, Inc.20241—
+6K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC20242—
+6K231798da Vinci SP Surgical SystemIntuitive Surgical, Inc.202311—
+6K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd.20230—
+6K213943SmartSurgN Visualization SystemSmartsurgn Incorporated20221—
+6K212871Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) ElectrodeGalvanize Therapeutics, Inc.20222—
+6K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20222—
+6K212101da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20212—
+6K211316da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202111
+6K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc.20215—
+6K211595da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202101
+6K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20203—
+6K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker20191—
+6K191482Senhance Surgical SystemTransenterix, Inc.20198—
+6K183098Senhance Surgical SystemTransenterix, Inc.20180—
+6K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201844—
+6K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker2018331
+6K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+6K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.201668—
+6K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+6K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201636—
+6K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy201476—
+6K133203Single-Site PortIntuitive Surgical, Inc.20140—
+7K253994TroKit Laparoscope Lens WiperTroCare, LLC20260—
+7K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.20260—
+7K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20260—
+7K242163SmartSurgN Visualization SystemSmartsurgN, Inc.20260—
+7K260089TL-10 Laparoscopic Scope CleanerScopix, Ltd.20260—
+7K253198NanoKnife Generator (H78720300351US0)Angiodynamics20260—
+7K250786SP Endoscope, 0° (430600)Intuitive Surgical, Inc.20251—
+7K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC20250—
+7K240502da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20249—
+7K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+7K2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+7K232773da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20240—
+7K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20241—
+7K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+7K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+7K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…Schoelly Fiberoptic GmbH20231—
+7K221861FloNavi Endoscopic Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20232—
+7K221252Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd.20230—
+7K222827da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20220—
+7K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation20220—
+7K212747Da Vinci SP Surgical SystemIntuitive Surgical, Inc.20210—
+7K203550ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20212—
+7K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207—
+7K203199RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single…STERIS Corporation20202—
+7K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker202026—
+7K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+7K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+7K2003101688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with…Stryker20200—
+7K191851VS3-IRMedtronic20196—
+7K192877Senhance Surgical SystemTransenterix, Inc.20197—
+7K191046L10 LED Light Source with AIM, L11 LED Light Source with AIMStryker20192—
+7K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+7K173866Stryker AIM Light Source and SafeLight cableStryker201834—
+7K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+7K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201732—
+7K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Stryker Endoscopy201534—
+8K254180PerfusiX-ImagingLIMIS Development B.V.20260—
+8K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+8K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+8K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+8K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+8K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20250—
+8K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+8K242318da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20247—
+8K241814da Vinci SP Instruments (SP1098)Intuitive Surgical, Inc.20240—
+8K241530Stellar Imaging SystemGuangdong Optomedic Technologies, Inc.20241—
+8K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+8K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—