FDA.reportPublic FDA data

510(k) K212049

Device
Oclet TDS 1000
Applicant
Tendonova Corporation
510(k) number
K212049
Product code
LFL
Decision
Substantially Equivalent (SESE)
Decision date
2022-03-08
Date received
2021-06-30
Classification name
Instrument, Ultrasonic Surgical
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mark Samuels
Address
3050 Business Park Dr., Suite A-2 Norcross GA US 30071 30071

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
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
K212614Ultrasonic Scalpel SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.2022-07-18