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510(k) K042160

Device
SONOSURG TROCAR
Applicant
AOMORI OLYMPUS CO., LTD.
510(k) number
K042160
Product code
LFL  
Decision
Substantially Equivalent (SESE)
Decision date
2005-01-25
Date received
2004-08-10
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
TINA STEFFANIE-OAK
Address
2 Corporate Center Dr. Melville NY US 11747 11747

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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