510(k) Report

Devices descending from K002906

69 later devices reach Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210567Ultrasonic Surgical SystemMiconvey Technologies Co., Ltd.20220—
+1K211273Harmonic Hand Piece, Blue, Harmonic Hand Piece, GrayEthicon Endo-Surgery, LLC20210—
+1K140459Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion Handpiece…Conmed Corporation201401
+1K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC20140—
+1K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.20121110
+1K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC201111—
+1K101797Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB…Covidien, Formerly Valleylab, A Division of Tyco20115—
+1K101534Conmed Altrus Thermal Tissue Fusion SystemConmedcorp201018
+1K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+1K042777Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36PEthicon Endo-Surgery, Inc.200439—
+2K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic…Shanghai Saints Sages Surgical Co., Ltd.20250—
+2K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+2K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+2K172691Ultrasonic GeneratorOlympus Medical Systems Corp.20174—
+2K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren20170—
+2K143562Reprocessed Cordless Ultrasonic Dissection DeviceSterilmed, Inc.20150—
+2K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC20149—
+2K141371Sonicision Cordless Ultrasonic DissectorCovidien, Formerly Valleylab, A Division of Tyco H20143—
+2K132703ThunderbeatOlympus Medical Systems Corp.20149—
+2K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+2K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+2K0932175 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System)Intuitive Surgical, Inc.2010163
+2K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+2K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+2K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+2K051036Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36PEthicon Endo-Surgery, Inc.200514—
+3K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+3K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+3K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+3K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+3K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+3K180575THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.20180—
+3K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.201843
+3K161825PK AIMGyrus Acmi, Inc.20162—
+3K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+3K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+3K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc.20152—
+3K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+3K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143—
+3K132522Harmonic Ace Curved Shears with Ergonomic HandleEthicon Endo-Surgery, LLC20130—
+3K132512Harmonic Ace Curved Shears with Scissor Handle, Harmonic Ace Curved Shears with…Ethicon Endo-Surgery, LLC20130—
+3K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+3K122605PKS BillGyrus Acmi, Inc.20121—
+3K1125845MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert, Disposable…Intuitive Surgical, Inc.2011151
+4K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+4K2104788mm Monopolar Curved ScissorsIconocare Health20220—
+4K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH202114
+4K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+4K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+4K182421Senhance Ultrasonic SystemTransenterix, Inc.20190—
+4K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc.20180—
+4K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+4K170908PK AIMGyrus Acmi, Inc.20170—
+4K163548ENSEAL X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20170—
+4K163373PK AIMGyrus Acmi, Inc.20161—
+4K143132IS4000 8mm Harmonic ACE Curved ShearsIntuitive Surgical, Inc.20159—
+5K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC20260—
+5K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+5K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions20240—
+5K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—
+5K170865EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…Intuitive Surgical, Inc.20178—
+6K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendIntuitive Surgical, Inc.201871
+7K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+8K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+8K191280E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc.201942
+9K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+10K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+11K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+12K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—