510(k) Report

Devices descending from K060245

52 later devices reach Harmonic Scalpel Blades and Shears through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151136Harmonic HookEthicon Endo-Surgery, LLC20161—
+1K132566Reprocessed Harmonic ShearSterilmed, Inc.20140—
+1K133672Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyStryker Sustainability Solutions20140—
+1K132522Harmonic Ace Curved Shears with Ergonomic HandleEthicon Endo-Surgery, LLC20130—
+1K132512Harmonic Ace Curved Shears with Scissor Handle, Harmonic Ace Curved Shears with…Ethicon Endo-Surgery, LLC20130—
+1K121550Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC201222
+1K120729Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue Technology…Ethicon Endo-Surgery, LLC201222—
+1K101797Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB…Covidien, Formerly Valleylab, A Division of Tyco20115—
+1K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+1K063531Series 3 Lotus Laparoscopic Ultrasound Surgery SystemSra Developments, Ltd.20072—
+2K254192Senhance Ultrasonic SystemAsensus Surgical20260—
+2K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+2K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+2K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren20170—
+2K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed…Sterilmed, Inc.20160—
+2K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+2K151405Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings (Dba Medline Renewal20160—
+2K151101Lotus Series 4 Ultrasonic Surgical System & AccessoriesSra Developments, Ltd.20151—
+2K143562Reprocessed Cordless Ultrasonic Dissection DeviceSterilmed, Inc.20150—
+2K141371Sonicision Cordless Ultrasonic DissectorCovidien, Formerly Valleylab, A Division of Tyco H20143—
+2K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+2K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+2K132612Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic…Ethicon Endo-Surgery, LLC2013161
+3K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic…Shanghai Saints Sages Surgical Co., Ltd.20250—
+3K221790HARMONIC 700 ShearsEthicon Endo-Surgery, LLC20231—
+3K221102LOTUS Series 4 Enhanced Shears, LOTUS Series 5Sra Developments, Ltd.20220—
+3K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20221—
+3K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+3K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+3K202554Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions20211—
+3K193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsSurgical Instrument Service and Savings Inc.(Dba Medline Ren202002
+3K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+3K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+3K170908PK AIMGyrus Acmi, Inc.20170—
+3K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+3K161693Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions201702
+3K160752HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm LengthEthicon Endo-Suregery, LLC20166—
+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—
+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
+4K250898Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears…Stryker Sustainability Solutions20250—
+4K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH202302
+4K200427Sonicision Cordless Ultrasonic DissectorCovidien, LLC20200—
+4K191555HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm lengthEthicon Endo-Surgery, LLC202052
+4K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc.20180—
+5K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+6K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC20260—
+6K243067The ETHICON™ Total Energy SystemEthicon Endo-Surgery, LLC (A Johnson and Johnson Company)20250—
+6K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…Stryker Sustainability Solutions20240—
+6K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…Stryker Sustainability Solutions20241—