510(k) Report

Devices descending from K000095

35 later devices reach Olympus Sonosurg Trocar XT3900 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042160Sonosurg TrocarAomori Olympus Co., Ltd.20050—
+1K041566Sonosurg Ultrasonic Surgical SystemAomori Olympus Co., Ltd.20040—
+1K031523Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd.200318—
+1K031305Olympus Ultrasonic Surgical SystemOlympus Optical Co., Ltd.200326—
+1K031710Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd.200318—
+1K021962Olympus Ultrasonic Surgical SystemThe Olympus Optical Co.200319—
+2K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.20121110
+2K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+2K050885Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation200515—
+2K032066Sonosurg SystemThe Olympus Optical Co.20031—
+3K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+3K172691Ultrasonic GeneratorOlympus Medical Systems Corp.20174—
+3K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+3K132703ThunderbeatOlympus Medical Systems Corp.20149—
+3K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+3K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+3K121550Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC201222
+4K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…Olympus Medical Systems Corp.20260—
+4K252150Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410)…Olympus Medical Systems Corporation202504
+4K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+4K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+4K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+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
+4K170908PK AIMGyrus Acmi, Inc.20170—
+4K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+4K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed…Sterilmed, Inc.20160—
+4K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+4K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+4K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+4K132566Reprocessed Harmonic ShearSterilmed, Inc.20140—
+5K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+5K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+5K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+6K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—