510(k) Report

Devices descending from K012176

27 later devices reach Ultracision Harmonic Scalpel Blades with Protective Sleeve, Models DH105… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+1K031305Olympus Ultrasonic Surgical SystemOlympus Optical Co., Ltd.200326—
+2K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+2K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+2K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+2K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.20121110
+2K042160Sonosurg TrocarAomori Olympus Co., Ltd.20050—
+2K041566Sonosurg Ultrasonic Surgical SystemAomori Olympus Co., Ltd.20040—
+3K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+3K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+3K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+3K172691Ultrasonic GeneratorOlympus Medical Systems Corp.20174—
+3K170908PK AIMGyrus Acmi, Inc.20170—
+3K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+3K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+3K150524Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings, Inc.20150—
+3K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20150—
+3K132703ThunderbeatOlympus Medical Systems Corp.20149—
+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
+4K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+4K180575THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.20180—
+4K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+4K172610THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm…Olympus Medical Systems Corp.201843
+4K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+5K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—