510(k) Report

Devices descending from K971861

269 later devices reach Ultrasonic Hand Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030598Medisiss Reprocessed Ultrasonic Surgical InstrumentsMedisiss20040—
+1K032424LOTUSSra Developments, Ltd.20033—
+1K980099Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))Ethicon Endo-Surgery, Inc.1998268—
+2K063531Series 3 Lotus Laparoscopic Ultrasound Surgery SystemSra Developments, Ltd.20072—
+2K043358Reprocessed Ultrasonic ScalpelsAlliance Medical Corp.20050—
+2K043315Vanguard Reprocessed Hand-Activated Ultrasonic ScalpelVanguard Medical Concepts, Inc.20050—
+2K043225Vanguard Reprocessed Ultrasonic ScalpelVanguard Medical Concepts, Inc.20050—
+2K993054Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1, CS-23C, CS-231…Ethicon Endo-Surgery, Inc.1999263—
+3K151101Lotus Series 4 Ultrasonic Surgical System & AccessoriesSra Developments, Ltd.20151—
+3K042777Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36PEthicon Endo-Surgery, Inc.200439—
+3K042855Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc.2004235—
+4K221102LOTUS Series 4 Enhanced Shears, LOTUS Series 5Sra Developments, Ltd.20220—
+4K210567Ultrasonic Surgical SystemMiconvey Technologies Co., Ltd.20220—
+4K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143—
+4K1125845MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert, Disposable…Intuitive Surgical, Inc.2011151
+4K101797Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB…Covidien, Formerly Valleylab, A Division of Tyco20115—
+4K0932175 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System)Intuitive Surgical, Inc.2010163
+4K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc.20091533
+4K051036Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36PEthicon Endo-Surgery, Inc.200514—
+4K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005229—
+4K043288Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005229—
+5K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.202213—
+5K2104788mm Monopolar Curved ScissorsIconocare Health20220—
+5K211784da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202114—
+5K202834da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202015—
+5K183086da Vinci X and Xi Surgical SystemIntuitive Surgical, Inc.202016—
+5K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2019204
+5K182421Senhance Ultrasonic SystemTransenterix, Inc.20190—
+5K182140da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201817—
+5K173585da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+5K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.20180—
+5K173842da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+5K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+5K172643da Vinci Xi Surgical System; da Vinci X Surgical SystemIntuitive Surgical, Inc.201818—
+5K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+5K171632da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201720—
+5K171699da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201714—
+5K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren20170—
+5K170713da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201722—
+5K161178da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201723—
+5K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201623—
+5K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc.201625—
+5K143562Reprocessed Cordless Ultrasonic Dissection DeviceSterilmed, Inc.20150—
+5K143132IS4000 8mm Harmonic ACE Curved ShearsIntuitive Surgical, Inc.20159—
+5K141371Sonicision Cordless Ultrasonic DissectorCovidien, Formerly Valleylab, A Division of Tyco H20143—
+5K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc.201412480
+5K132522Harmonic Ace Curved Shears with Ergonomic HandleEthicon Endo-Surgery, LLC20130—
+5K132512Harmonic Ace Curved Shears with Scissor Handle, Harmonic Ace Curved Shears with…Ethicon Endo-Surgery, LLC20130—
+5K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc.2013396
+5K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc.20121482
+5K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.20121110
+5K112263Monopolar Curved Scissors Tip Cover AccessoryIntuitive Surgical, Inc.2011271
+5K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist…Intuitive Surgical, Inc.200801
+5K072627Intuitive Surgical DA Vinci and DA Vinci S Surgical System and Endoscopic Instruments…Intuitive Surgical, Inc.20080—
+5K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20062244
+5K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005228—
+6K252926Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical…Restore Robotics20260—
+6K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.20250—
+6K233866Senhance Surgical SystemAsensus Surgical, Inc.20240—
+6K240723da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical20241—
+6K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+6K231224da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.202313—
+6K223095Senhance Surgical SystemAsensus Surgical, Inc.20231Class I
+6K2200238mm Monopolar Curved ScissorsIntuitive Surgical, Inc.202211
+6K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+6K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+6K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2020141
+6K192717da Vinci SP Surgical SystemIntuitive Surgical, Inc.202041
+6K192803da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical20200—
+6K180351EndoWrist Mercury Bipolar GrasperIntuitive Surgical, Inc.201802
+6K172691Ultrasonic GeneratorOlympus Medical Systems Corp.20174—
+6K170875da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments…Intuitive Surgical, Inc.20170—
+6K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeIntuitive Surgical, Inc.20171—
+6K171294da Vinci X Surgical SystemIntuitive Surgical, Inc.20173110
+6K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+6K161271da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201613—
+6K152892da Vinci Xi Surgical SystemIntuitive Surgical201612—
+6K152448da Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc.2016101
+6K151794da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201612—
+6K150284IS4000 da Vinci EndoWrist InstrumentsIntuitive Surgical, Inc.201508
+6K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsIntuitive Surgical, Inc.201503
+6K14268312 mm Endoscopes and AccessoriesIntuitive Surgical, Inc.20141—
+6K141075Single-Site Wristed Needle DriverIntuitive Surgical20141—
+6K141272Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield 10MM Endoscopic…Minimmally Invasive Devices20144—
+6K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.2014872
+6K132703ThunderbeatOlympus Medical Systems Corp.20149—
+6K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.201422—
+6K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200921125
+6K081207Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA Vinci Connect and…Intuitive Surgical, Inc.20087—
+6K073112DA Vinci Sonicpro Cleaning System, Model 400253Intuitive Surgical, Inc.20085—
+6K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc.20061541
+6K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc.20061551
+7K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+7K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+7K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+7K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+7K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix20250—
+7K250539Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix20250—
+7K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix20250—
+7K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix20250—