LFL — Instrument, Ultrasonic Surgical Class U

FDA Device Classification

Classification Details

Product Code
LFL
Device Class
Class U
Regulation Number
Submission Type
Review Panel
SU
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251162integra lifesciences corporationCUSA® Clarity Ultrasonic Surgical Aspirator SystemOctober 8, 2025
K242894shanghai saints sages surgical coSanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ UltrJune 18, 2025
K243930stryker instrumentsSonopet iQ Ultrasonic Aspirator System (5500-050-000)March 24, 2025
K241700trice medicalTenex 2nd Generation SystemNovember 18, 2024
K240493integra lifesciences corporationCUSA® Clarity Ultrasonic Surgical Aspirator SystemJuly 11, 2024
K233036hunan handlike minimally invasive surgery coUltrasonic Surgical SystemJune 18, 2024
K230427integra lifesciences corporationCUSA Clarity Ultrasonic Surgical Aspirator SystemJuly 11, 2023
K231117misonix, llc, a bioventusneXus Ultrasonic Surgical Aspirator SystemJune 23, 2023
K221790ethicon endo-surgeryHARMONIC 700 ShearsFebruary 28, 2023
K223770stryker corporationSonopet 1Q 3 7cm 1Q LargeFebruary 16, 2023
K221102sra developmentsLOTUS Series 4 Enhanced Shears, LOTUS Series 5December 15, 2022
K210567miconvey technologies coUltrasonic Surgical SystemSeptember 30, 2022
K221835integra lifesciences corporationCUSA Clarity Ultrasonic Surgical Aspirator SystemAugust 22, 2022
K221235misonixneXus Ultrasonic Surgical Aspirator SystemJuly 28, 2022
K212614surgnova healthcare technologies (zhejiang) coUltrasonic Scalpel SystemJuly 18, 2022
K221763integra lifesciences corporationCUSA Clarity Ultrasonic Surgical Aspirator SystemJuly 15, 2022
K212049tendonova corporationOclet TDS 1000March 8, 2022
K213824stryker corporationSonopet iQ Ultrasonic Aspirator SystemFebruary 3, 2022
K212060misonixneXus Ultrasonic Surgical Aspirator SystemDecember 13, 2021
K212301covidienSonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceNovember 15, 2021