510(k) Report

Devices descending from K013946

340 later devices reach Flex 10 Accessory for the Afx Microwave Ablation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+7K253846Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…Hangzhou Ruidi Biotechnology, Ltd.20260—
+7K253994TroKit Laparoscope Lens WiperTroCare, LLC20260—
+7K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.20260—
+7K242163SmartSurgN Visualization SystemSmartsurgN, Inc.20260—
+7K260089TL-10 Laparoscopic Scope CleanerScopix, Ltd.20260—
+7K250786SP Endoscope, 0° (430600)Intuitive Surgical, Inc.20251—
+7K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC20250—
+7K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…AngioDynamics, Inc.20241—
+7K241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.20240—
+7K241825Microwave Ablation AntennasCanyon Medical, Inc.20240—
+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—
+7K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.20240—
+7K240518swiftPro™ SystemEmblation Limited20241—
+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—
+7K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+7K223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20231—
+7K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd.20230—
+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—
+7K221672Creo Electrosurgical System with NP1 InstrumentCreo Medical, Ltd.20230—
+7K221252Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd.20230—
+7K222827da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20220—
+7K212871Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) ElectrodeGalvanize Therapeutics, Inc.20222—
+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—
+8K253826Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20260—
+8K253198NanoKnife Generator (H78720300351US0)Angiodynamics20260—
+8K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.20260—
+8K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14…Nanjing Devin Medical Technology Co., Ltd.20260—
+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—
+8K242983CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd.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—
+8K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20241—
+8K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+8K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+8K231344ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20230—
+8K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+8K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+8K223020VS3-Iridium System (VS3-IR)Visionsense, Ltd.20220—
+8K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20221—
+8K210265VS3 Iridium SytemVisionsense, Ltd.20215—
+8K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+8K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker202125—
+8K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+8K200049Senhance Surgical SystemTransenterix, Inc.20206—
+8K191280E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc.201942
+8K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+8K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc.201830—
+8K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201731—
+9K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG20260—
+9K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+9K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+9K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+9K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+9K2526973D LaparoscopeGuangdong Optomedic Technologies, Inc.20250—
+9K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+9K251324da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+9K243714da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20255—
+9K243008Arthrex NanoScope SystemArthrex, Inc.20254—
+9K233391cCeLL - In vivoVPIX Medical, Inc.20240—
+9K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+9K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—