510(k) Report

Devices descending from K040948

229 later devices reach Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/N 400170 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker2018331
+5K181517Senhance Surgical SystemTransenterix, Inc.201810—
+5K180163TransEnterix Senhance Surgical SystemTransenterix, Inc.201811—
+5K170879IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30…Intuitive Surgical, Inc.20170—
+5K170875da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments…Intuitive Surgical, Inc.20170—
+5K171388EndoWrist Stapler 45 System and Stapler 45 ReloadsIntuitive Surgical, Inc.20171—
+5K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.201668—
+5K152448da Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc.2016101
+5K141075Single-Site Wristed Needle DriverIntuitive Surgical20141—
+5K141272Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield 10MM Endoscopic…Minimmally Invasive Devices20144—
+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
+6K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.20260—
+6K250786SP Endoscope, 0° (430600)Intuitive Surgical, Inc.20251—
+6K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC20250—
+6K240502da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20249—
+6K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+6K2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+6K232773da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20240—
+6K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+6K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+6K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…Schoelly Fiberoptic GmbH20231—
+6K221861FloNavi Endoscopic Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20232—
+6K221252Scivita 4KINSIGHT ICG Imaging SystemScivita Medical Technology Co., Ltd.20230—
+6K213943SmartSurgN Visualization SystemSmartsurgn Incorporated20221—
+6K222827da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20220—
+6K212808Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation20220—
+6K212747Da Vinci SP Surgical SystemIntuitive Surgical, Inc.20210—
+6K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207—
+6K203199RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single…STERIS Corporation20202—
+6K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker202026—
+6K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+6K2003101688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with…Stryker20200—
+6K191851VS3-IRMedtronic20196—
+6K191482Senhance Surgical SystemTransenterix, Inc.20198—
+6K191046L10 LED Light Source with AIM, L11 LED Light Source with AIMStryker20192—
+6K183098Senhance Surgical SystemTransenterix, Inc.20180—
+6K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+6K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201636—
+6K150705FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic…Minimally Invasive Devices, Inc.20153—
+6K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy201476—
+6K133203Single-Site PortIntuitive Surgical, Inc.20140—
+7K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+7K242163SmartSurgN Visualization SystemSmartsurgN, Inc.20260—
+7K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+7K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+7K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+7K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20250—
+7K242318da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20247—
+7K241814da Vinci SP Instruments (SP1098)Intuitive Surgical, Inc.20240—
+7K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC20242—
+7K241530Stellar Imaging SystemGuangdong Optomedic Technologies, Inc.20241—
+7K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+7K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+7K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+7K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+7K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+7K223020VS3-Iridium System (VS3-IR)Visionsense, Ltd.20220—
+7K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20221—
+7K210265VS3 Iridium SytemVisionsense, Ltd.20215—
+7K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+7K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker202125—
+7K203550ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20212—
+7K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+7K200542Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video…Olympus Medical Systems Corp.20200—
+7K192877Senhance Surgical SystemTransenterix, Inc.20197—
+7K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+7K173866Stryker AIM Light Source and SafeLight cableStryker201834—
+7K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201732—
+7K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Stryker Endoscopy201534—
+8K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG20260—
+8K254180PerfusiX-ImagingLIMIS Development B.V.20260—
+8K253994TroKit Laparoscope Lens WiperTroCare, LLC20260—
+8K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+8K260089TL-10 Laparoscopic Scope CleanerScopix, Ltd.20260—
+8K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+8K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+8K2526973D LaparoscopeGuangdong Optomedic Technologies, Inc.20250—
+8K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+8K251324da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+8K243714da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20255—
+8K243008Arthrex NanoScope SystemArthrex, Inc.20254—
+8K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+8K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+8K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG20230—
+8K231344ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20230—
+8K222240Explorer Air® IISurgvision GmbH20231—
+8K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20220—
+8K221217SPY LaparoscopeStryker20221—
+8K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies20221—
+8K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119—
+8K200049Senhance Surgical SystemTransenterix, Inc.20206—
+8K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+8K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc.201830—
+8K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201731—
+9K253602Precision S 4K SinuscopeStryker Endoscopy20260—
+9K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.20260—
+9K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+9K252675da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—