510(k) Report

Devices descending from K953637

424 later devices reach CMS Accuprobe 550/530 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K233884INUMI™ Flex NeedleGalvanize Therapeutics, Inc.20241—
+10K240518swiftPro™ SystemEmblation Limited20241—
+10K233140Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)Hygea Medical Technology Co., Ltd.20240—
+10K232240Microwave Ablation System (BD-GT)Betters (Suzhou) Medical Co., Ltd.20231—
+10K232241Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818…Betters (Suzhou) Medical Co., Ltd.20231—
+10K233170cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…AtriCure, Inc.20230—
+10K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+10K223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20231—
+10K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+10K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…Schoelly Fiberoptic GmbH20231—
+10K221861FloNavi Endoscopic Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20232—
+10K221672Creo Electrosurgical System with NP1 InstrumentCreo Medical, Ltd.20230—
+10K221252Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd.20230—
+10K222827da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20220—
+10K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation20220—
+10K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+10K212747Da Vinci SP Surgical SystemIntuitive Surgical, Inc.20210—
+10K203550ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20212—
+10K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207—
+10K203199RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single…STERIS Corporation20202—
+10K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker202026—
+10K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+10K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+10K2003101688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with…Stryker20200—
+10K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—
+10K191851VS3-IRMedtronic20196—
+10K192877Senhance Surgical SystemTransenterix, Inc.20197—
+10K191046L10 LED Light Source with AIM, L11 LED Light Source with AIMStryker20192—
+10K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+10K173866Stryker AIM Light Source and SafeLight cableStryker201834—
+10K171522truFreeze Rapid AV Spray KitCSA Medical, Inc.20170—
+10K163244truFreeze SystemCSA Medical, Inc.20175—
+10K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+10K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201732—
+10K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Stryker Endoscopy201534—
+11K254180PerfusiX-ImagingLIMIS Development B.V.20260—
+11K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+11K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.20260—
+11K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14…Nanjing Devin Medical Technology Co., Ltd.20260—
+11K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+11K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+11K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+11K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20250—
+11K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+11K242983CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd.20250—
+11K242318da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20247—
+11K241814da Vinci SP Instruments (SP1098)Intuitive Surgical, Inc.20240—
+11K241530Stellar Imaging SystemGuangdong Optomedic Technologies, Inc.20241—
+11K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—
+11K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+11K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+11K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+11K231344ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20230—
+11K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+11K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+11K223020VS3-Iridium System (VS3-IR)Visionsense, Ltd.20220—
+11K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20221—
+11K210265VS3 Iridium SytemVisionsense, Ltd.20215—
+11K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+11K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker202125—
+11K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+11K200049Senhance Surgical SystemTransenterix, Inc.20206—
+11K191280E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc.201942
+11K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+11K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc.201830—
+11K171626truFreeze SystemCSA Medical, Inc.20173—
+11K172041truFreeze SystemCSA Medical, Inc.20170—
+11K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201731—
+12K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG20260—
+12K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+12K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+12K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+12K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+12K2526973D LaparoscopeGuangdong Optomedic Technologies, Inc.20250—
+12K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+12K251324da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+12K243714da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20255—
+12K243008Arthrex NanoScope SystemArthrex, Inc.20254—
+12K233391cCeLL - In vivoVPIX Medical, Inc.20240—
+12K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+12K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+12K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG20230—
+12K222240Explorer Air® IISurgvision GmbH20231—
+12K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+12K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20220—
+12K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20221—
+12K221217SPY LaparoscopeStryker20221—
+12K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies20221—
+12K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119—
+12K202166Senhance Surgical SystemTransenterix, Inc.20215—
+12K201183Vortex Radial Spray CatheterCSA Medical, Inc.20200—
+12K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid…Karl Storz-Endoscopy-America, Inc.20208—
+12K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+12K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+13K253602Precision S 4K SinuscopeStryker Endoscopy20260—
+13K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.20260—
+13K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+13K252675da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+13K252069da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+13K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—