510(k) Report

Devices descending from K131861

124 later devices reach DA Vinci Surgical System, Endowrist Instruments and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252926Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical…Restore Robotics20260—
+1K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.20250—
+1K240723da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical20241—
+1K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+1K231224da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202313—
+1K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.202213—
+1K2200238mm Monopolar Curved ScissorsIntuitive Surgical, Inc.202211
+1K211784da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202114—
+1K202834da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202015—
+1K192803da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical20200—
+1K183086da Vinci X and Xi Surgical SystemIntuitive Surgical, Inc.202016—
+1K182140da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201817—
+1K180351EndoWrist Mercury Bipolar GrasperIntuitive Surgical, Inc.201802
+1K173585da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+1K173842da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+1K172643da Vinci Xi Surgical System; da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+1K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+1K171632da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201720—
+1K171699da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201714—
+1K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeIntuitive Surgical, Inc.20171—
+1K170713da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201722—
+1K171294da Vinci X Surgical SystemIntuitive Surgical, Inc.20173110
+1K161178da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201723—
+1K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201623—
+1K161271da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201613—
+1K152892da Vinci Xi Surgical SystemIntuitive Surgical201612—
+1K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc.201625—
+1K151794da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201612—
+1K150284IS4000 da Vinci EndoWrist InstrumentsIntuitive Surgical, Inc.201508
+1K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsIntuitive Surgical, Inc.201503
+1K14268312 mm Endoscopes and AccessoriesIntuitive Surgical, Inc.20141—
+1K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.2014872
+2K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+2K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+2K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+2K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+2K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+2K2514908 mm Assist Cannula; 12 mm Assist CannulaIntuitive Surgical, Inc.20250—
+2K242427da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.20250—
+2K2426108mm Monopolar Curved Scissors (470179)Iconocare Health20250—
+2K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+2K233866Senhance Surgical SystemAsensus Surgical, Inc.20240—
+2K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+2K223095Senhance Surgical SystemAsensus Surgical, Inc.20231Class I
+2K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20216—
+2K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical202012—
+2K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30Intuitive Surgical20190—
+2K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016701
+3K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+3K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+3K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+3K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+3K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20222—
+3K212101da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20212—
+3K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc.20215—
+3K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker20191—
+3K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201844—
+3K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker2018331
+3K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.201668—
+4K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.20260—
+4K250786SP Endoscope, 0° (430600)Intuitive Surgical, Inc.20251—
+4K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC20250—
+4K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+4K2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+4K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+4K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+4K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…Schoelly Fiberoptic GmbH20231—
+4K221861FloNavi Endoscopic Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20232—
+4K221252Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd.20230—
+4K222827da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20220—
+4K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation20220—
+4K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207—
+4K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker202026—
+4K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+4K2003101688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with…Stryker20200—
+4K191851VS3-IRMedtronic20196—
+4K191046L10 LED Light Source with AIM, L11 LED Light Source with AIMStryker20192—
+5K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+5K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+5K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+5K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+5K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20250—
+5K241530Stellar Imaging SystemGuangdong Optomedic Technologies, Inc.20241—
+5K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+5K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+5K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+5K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+5K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+5K223020VS3-Iridium System (VS3-IR)Visionsense, Ltd.20220—
+5K210265VS3 Iridium SytemVisionsense, Ltd.20215—
+5K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+5K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker202125—
+5K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+6K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG20260—
+6K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+6K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+6K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+6K2526973D LaparoscopeGuangdong Optomedic Technologies, Inc.20250—
+6K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+6K243008Arthrex NanoScope SystemArthrex, Inc.20254—