510(k) Report

Devices descending from K925699

468 later devices reach Harmonic Scalpel Laparosonic Clamp Coagulator Acc. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+5K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2020141
+5K192717da Vinci SP Surgical SystemIntuitive Surgical, Inc.202041
+5K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+5K192803da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical20200—
+5K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+5K180351EndoWrist Mercury Bipolar GrasperIntuitive Surgical, Inc.201802
+5K180575THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.20180—
+5K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.201843
+5K170875da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments…Intuitive Surgical, Inc.20170—
+5K171426da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeIntuitive Surgical, Inc.20171—
+5K171294da Vinci X Surgical SystemIntuitive Surgical, Inc.20173110
+5K170908PK AIMGyrus Acmi, Inc.20170—
+5K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+5K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+5K161271da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201613—
+5K161122Sony IP Converter NU-IP40SSony Electronics, Inc.20161—
+5K152892da Vinci Xi Surgical SystemIntuitive Surgical201612—
+5K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+5K152448da Vinci Single-Site Instrument and AccessoriesIntuitive Surgical, Inc.2016101
+5K151794da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201612—
+5K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+5K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+5K150284IS4000 da Vinci EndoWrist InstrumentsIntuitive Surgical, Inc.201508
+5K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsIntuitive Surgical, Inc.201503
+5K14268312 mm Endoscopes and AccessoriesIntuitive Surgical, Inc.20141—
+5K141075Single-Site Wristed Needle DriverIntuitive Surgical20141—
+5K141272Floshield 10MM Endoscopic Cannula and Blunt Obturator, Floshield 10MM Endoscopic…Minimmally Invasive Devices20144—
+5K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.2014872
+5K131962DA Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.201422—
+5K091648Nurse's Assistant O.R. Control System ,1.8Conmed Integrated Systems (Cmis)20090—
+5K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200921125
+5K081207Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA Vinci Connect and…Intuitive Surgical, Inc.20087—
+5K073112DA Vinci Sonicpro Cleaning System, Model 400253Intuitive Surgical, Inc.20085—
+5K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc.20087239
+5K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc.20061541
+5K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc.2006803
+5K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc.20061551
+5K051613Modification to Olympus Integrated Endosurgery System Endoalpha (Control Unit for…Olympus Medical Systems Corporation20055—
+6K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262—
+6K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+6K250417Remanufactured EndoWrist Cobra Grasper (420190)Rebotix20250—
+6K250539Remanufactured EndoWrist Tenaculum Forceps (420207)Rebotix20250—
+6K250387Remanufactured EndoWrist Long Tip Forceps (420048)Rebotix20250—
+6K250399Remanufactured EndoWrist Cadiere Forceps (420049)Rebotix20250—
+6K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250—
+6K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250—
+6K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251—
+6K2514908 mm Assist Cannula; 12 mm Assist CannulaIntuitive Surgical, Inc.20250—
+6K242427da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.20250—
+6K2426108mm Monopolar Curved Scissors (470179)Iconocare Health20250—
+6K243582da Vinci SP Advanced Access Port Kit (432701)Intuitive Surgical, Inc.20250—
+6K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241—
+6K241872Remanufactured EndoWrist ProGrasp Forceps (420093)Rebotix20240—
+6K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242—
+6K230033Da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202312—
+6K210918da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20216—
+6K202968Da Vinci SP Surgical SystemIntuitive Surgical, Inc.202031
+6K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+6K191529da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical202012—
+6K191678IP ConverterSony Electronics, Inc.20200—
+6K190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20194—
+6K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30Intuitive Surgical20190—
+6K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+6K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.2018219
+6K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+6K171120Senhance Surgical Robotic SystemTransenterix, Inc.201712—
+6K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016701
+6K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+6K150705FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic…Minimally Invasive Devices, Inc.20153—
+6K123840Connect for DA Vinci Surgical System (S)Intuitive Surgical, Inc.20130—
+6K121921Intuitive Surgical Onsite for DA Vinci Surgical SystemsIntuitive Surgical, Inc.20120—
+6K113706Endowrist Stapler SystemIntuitive Surgical, Inc.201221
+6K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.20114312
+6K101581Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci Onsite…Intuitive Surgical, Inc.20116—
+6K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20111042
+6K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+6K100852Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications20102—
+6K100345Systems Integration Model: EndoalphaOlympus Medical Systems Corporation20101—
+6K091166IMRXImris, Inc.20091—
+6K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc.2009697
+6K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+6K080614DR Vision Neo, DR Vision DouAlmana Medical Imaging20080—
+6K080291Intuitive Surgical DA Vinci Endoscopic Instruments and Control System and Endowrist…Intuitive Surgical, Inc.200801
+6K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+7K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+7K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.20260—
+7K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+7K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc.20260—
+7K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+7K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC20242—
+7K231798da Vinci SP Surgical SystemIntuitive Surgical, Inc.202311—
+7K223060DigiX FDXAllengers Medical Systems Limited20224—
+7K220149General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System…Xera Medical Systems & Technology, Ltd.20220—
+7K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20222—
+7K212101da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20212—
+7K211316da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202111
+7K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc.20215—
+7K211595da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.202101
+7K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber…STERIS Corporation20203—