510(k) Report

Devices descending from K081137

211 later devices reach Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix20250—
+1K250539Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix20250—
+1K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix20250—
+1K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix20250—
+1K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix20240—
+1K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.202213—
+1K2104788mm Monopolar Curved ScissorsIconocare Health20220—
+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—
+1K183086da Vinci X and Xi Surgical SystemIntuitive Surgical, Inc.202016—
+1K182140da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201817—
+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—
+1K171120Senhance Surgical Robotic SystemTransenterix, Inc.201712—
+1K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+1K171632da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201720—
+1K170713da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201722—
+1K161178da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201723—
+1K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201623—
+1K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc.201625—
+1K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143—
+1K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.201422—
+1K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc.2013396
+1K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc.20121482
+1K113706Endowrist Stapler SystemIntuitive Surgical, Inc.201221
+1K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.20114312
+1K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20111042
+1K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc.20091533
+2K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.20250—
+2K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+2K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2019204
+2K181517Senhance Surgical SystemTransenterix, Inc.201810—
+2K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.20180—
+2K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2018219
+2K180163TransEnterix Senhance Surgical SystemTransenterix, Inc.201811—
+2K170879IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30…Intuitive Surgical, Inc.20170—
+2K170875da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments…Intuitive Surgical, Inc.20170—
+2K171699da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201714—
+2K171388EndoWrist Stapler 45 System and Stapler 45 ReloadsIntuitive Surgical, Inc.20171—
+2K152448da Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc.2016101
+2K141075Single-Site Wristed Needle DriverIntuitive Surgical20141—
+2K141272Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield 10MM Endoscopic…Minimmally Invasive Devices20144—
+2K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.2014872
+2K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc.201412480
+2K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc.2013103—
+2K130726DA Vinci Single-Site Permanent Cautery HookIntuitive Surgical, Inc.201327
+2K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Intuitive Surgical, Inc.2012423
+2K112263Monopolar Curved Scissors Tip Cover AccessoryIntuitive Surgical, Inc.2011271
+3K252926Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical…Restore Robotics20260—
+3K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+3K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+3K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+3K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+3K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+3K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+3K233866Senhance Surgical SystemAsensus Surgical, Inc.20240—
+3K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+3K240723da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical20241—
+3K231224da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202313—
+3K223095Senhance Surgical SystemAsensus Surgical, Inc.20231Class I
+3K213943SmartSurgN Visualization SystemSmartsurgn Incorporated20221—
+3K2200238mm Monopolar Curved ScissorsIntuitive Surgical, Inc.202211
+3K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20216—
+3K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2020141
+3K192717da Vinci SP Surgical SystemIntuitive Surgical, Inc.202041
+3K192803da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical20200—
+3K191482Senhance Surgical SystemTransenterix, Inc.20198—
+3K183098Senhance Surgical SystemTransenterix, Inc.20180—
+3K180351EndoWrist Mercury Bipolar GrasperIntuitive Surgical, Inc.201802
+3K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeIntuitive Surgical, Inc.20171—
+3K171294da Vinci X Surgical SystemIntuitive Surgical, Inc.20173110
+3K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+3K161271da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201613—
+3K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201636—
+3K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016701
+3K152892da Vinci Xi Surgical SystemIntuitive Surgical201612—
+3K151794da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201612—
+3K150284IS4000 da Vinci EndoWrist InstrumentsIntuitive Surgical, Inc.201508
+3K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsIntuitive Surgical, Inc.201503
+3K150705FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic…Minimally Invasive Devices, Inc.20153—
+3K14268312 mm Endoscopes and AccessoriesIntuitive Surgical, Inc.20141—
+3K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy201476—
+3K133203Single-Site PortIntuitive Surgical, Inc.20140—
+4K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+4K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+4K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+4K242163SmartSurgN Visualization SystemSmartsurgN, Inc.20260—
+4K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+4K2514908 mm Assist Cannula; 12 mm Assist CannulaIntuitive Surgical, Inc.20250—
+4K242427da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.20250—
+4K2426108mm Monopolar Curved Scissors (470179)Iconocare Health20250—
+4K243582da Vinci SP Advanced Access Port Kit (432701)Intuitive Surgical, Inc.20250—
+4K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC20242—
+4K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202312—
+4K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20222—
+4K212101da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20212—
+4K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc.20215—
+4K203550ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20212—
+4K202968Da Vinci SP Surgical SystemIntuitive Surgical, Inc.202031