510(k) Report

Devices descending from K944602

319 later devices reach Valleylab Force FX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K111600Reprocessed Hand Activate Sealer/DividerAscent Healthcare Solutions20110—
+3K110695Bipolar HF DeviceAesculap, Inc.20110—
+3K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC201111—
+3K102470Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab,201164—
+3K092383Bovie Icon VS General Purpose RF Generator, Model: VS300Bovie Medical Corporation20100—
+3K093075Aragon Surgical RF System Teleo InstrumentAragon Surgical, Inc.201072
+3K091259Ethicon Endo-Surgery Flexible Bipolar Hemostasis ForcepsEthicon Endo-Surgery, Inc.20100—
+3K092879Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab2009651
+3K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+3K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc.2008241
+3K081503Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc.20087—
+3K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+3K071728Modification to: Enseal PTC Tissue Sealing DeviceSurgrx, Inc.200716—
+3K062525Reprocessed Ligasure Vessel Sealer/DividerAscent Healthcare Solutions20070—
+3K063195Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034…Valleylab200631—
+3K061975Plasmaseal Open Forceps, Models 2103PK and 91701PKAcmi Corporation20064—
+3K061526Enseal PTC Tissue Sealing DeviceSurgrx, Inc.200653—
+3K050671Enseal Vessel Sealing & Hemostasis SystemSurgrx, Inc.200526—
+3K043008Surgrx Enseal Vessel Sealing & Hemostasis SystemSurgrx, Inc.200425—
+3K041587Ligasure Precise Model #LS1200/Ligasure 5MM Laparoscopic Sealer Divider Model # LS1500Valleylab200411—
+4K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+4K253634CoolSeal Generator® (CSL-200-90)Hologic, Inc.20260—
+4K254220Reusable 3 Button Fingerswitch WandSoniquence, LLC20260—
+4K252412Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)Applied Medical Resources Corporation20250—
+4K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+4K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic…Shanghai Saints Sages Surgical Co., Ltd.20250—
+4K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+4K231126Eblator DeviceE Surgical, LLC20231—
+4K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+4K222793WavelinQ™ GeneratorC.R. Bard, Inc.20220—
+4K212222Soniquence Reusable 3 Button Fingerswitch WandSoniquence, LLC20221—
+4K202106Plasmage SystemBrera Medical, Inc.20220—
+4K220071Soniquence Reusable Neutral PlateSoniquence, LLC20220—
+4K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm…Bolder Surgical, LLC20211—
+4K203461Aesculap Caiman 12 Seal and Cut Technology SystemAesculap, Inc.20200—
+4K202562Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips…Ellusa, LLC20201—
+4K200241TempSure SystemCynosure, LLC202013—
+4K193579PlasmaBlade X 3.0S LIGHTMedtronic Navigation20202—
+4K192813Plasma IQNeauvia North America, Inc.202012—
+4K193292Voyant 5mm Fusion Device, Voyant Maryland Fusion DeviceApplied Medical Resources Corp.20194—
+4K182244Voyant Electrosurgical GeneratorApplied Medical Resources Corp.20181—
+4K180575THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.20180—
+4K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.201843
+4K172624Voyant 5mm Fusion DeviceApplied Medical Resources Corporation20186—
+4K172757Valleylab FX8 Electrosurgical PlatformCovidien, LLC20176—
+4K170054iSurgJaco, LLC Dba Macan Manufacturing and Bna Burz North America20170—
+4K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency…Bovie Medical Corporation2017116
+4K170170Valleylab FT10 Electrosurgical PlatformCovidien, LLC20178—
+4K162676Voyant Open Fusion DeviceApplied Medical Resources20163—
+4K161825PK AIMGyrus Acmi, Inc.20162—
+4K161804LigaSure Retractable L-Hook Laparoscopic Sealer/DividerCovidien20160—
+4K162047LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coatedCovidien20163—
+4K160554Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20166—
+4K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation201623
+4K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+4K153745Medline ReNewal Reprocessed LigaSure Impact Open Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren201604
+4K160041Cobbra RF Tissue DissectorElliquence, LLC20166—
+4K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+4K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+4K153499EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy…Conmed Corporation20150—
+4K152219PK AIMGyrus Acmi, Inc.20153—
+4K142410Elliquence ElectrodesElliquence, LLC20157—
+4K150835LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol GripCovidien20151—
+4K152286LigaSure Curved, Small Jaw, Open Sealer/DividerCovidien201514—
+4K151696Caiman Seal and Cut TechnologyAesculap, Inc.20152—
+4K150538Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/DividerStryker Sustainability Solutions20150—
+4K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+4K143536Voyant Fine Fusion DeviceApplied Medical Resources20152—
+4K143517Voyant Open Sealer-Divider DeviceApplied Medical Resources201511
+4K143260Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/DividerSterilmed, Inc.20150—
+4K143175AEx Generator; PlasmaBlade TMedtronic Advanced Energy20141—
+4K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC20149—
+4K141153Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…Covidien201440—
+4K140839Caiman Seal and Cut TechnologyAesculap, Inc.20141—
+4K133338Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H201343—
+4K130266Endowrist One Vessel SealerIntuitive Surgical, Inc.2013101
+4K130744Ligasure 5MM Blunt Tip Laparoscopic Sealer/DividerCovidien201342—
+4K121881Domain Surgical SystemDomain Surgical, Inc.20124—
+4K113572Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H201262—
+4K121678DTADGyrus Acmi, Inc.20122—
+4K110639Endowrist One Vessel SealerIntuitive Surgical, Inc.2011152
+4K103508Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc.20116—
+4K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+4K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+4K102029Peak Pulsar II Generator Model PS100-102Peak Surgical, Inc.20100—
+4K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc.20108—
+4K070896Enseal PTC Tissue Sealing DeviceSurgrx, Inc.2007321
+4K070165Enseal PTC TrioSurgrx, Inc.2007251
+4K062949Enseal PTC Tissue Seating Sealing DeviceSurgrx, Inc.200626—
+4K063097Enseal PTC Tissue Sealing DeviceSurgrx, Inc.200634—
+5K252487POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)Gyrus Acmi, Inc.20260—
+5K251899E BlatorNew Deantronics Taiwan, Ltd.20250—
+5K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+5K242266PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments20241—
+5K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+5K230621LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic ProbesSurgical Principals, Inc.20230—
+5K231012CoolSeal TrinityBolder Surgical, LLC20230—
+5K222425Ellusa Reusable Neutral PlatesEllusa, LLC20220—
+5K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+5K220411Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions20221—