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510(k) K180149

Device
Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple Lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
Applicant
Covidien, Llc
510(k) number
K180149
Product code
LFL  
Decision
Substantially Equivalent (SESE)
Decision date
2018-03-26
Date received
2018-01-19
Regulation
510(k) Premarket Notification
Classification name
Instrument, Ultrasonic Surgical
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Nancy Sauer
Address
5920 Longbow Dr. Boulder CO US 80301 80301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LFL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC2026-07-30
K251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation2025-10-08
K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)Shanghai Saints Sages Surgical Co., Ltd.2025-06-18
K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)Stryker Instruments2025-03-24
K241700Tenex 2nd Generation SystemTrice Medical, Inc.2024-11-18
K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation2024-07-11
K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.2024-06-18
K230427CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation2023-07-11
K231117neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC, A Bioventus Company2023-06-23
K221790HARMONIC 700 ShearsEthicon Endo-Surgery, LLC2023-02-28
K223770Sonopet 1Q 3 7cm 1Q LargeStryker Corporation2023-02-16
K221102LOTUS Series 4 Enhanced Shears, LOTUS Series 5Sra Developments, Ltd.2022-12-15
K210567Ultrasonic Surgical SystemMiconvey Technologies Co., Ltd.2022-09-30
K221835CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation2022-08-22
K221235neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc.2022-07-28

Legacy Summary#

summary

FDA Review#

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