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HIF — Insufflator, Laparoscopic Class II

FDA Device Classification

Classification Details

Product Code
HIF
Device Class
Class II
Regulation Number
884.1730
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250388karl storz se and co. kgENDOFLATOR +September 22, 2025
K242772smartsurgnAirSurgN Insufflator (10030/AirSurgN)April 11, 2025
K243527olympus medical systems corporationHigh Flow Insufflation Unit (UHI-4)January 13, 2025
K242536tautona groupTauTona Pneumoperitoneum Assist Device (TPAD)October 15, 2024
K232464freyja healthcareVereSee Optical Veres Needle SystemMay 2, 2024
K232902palliareEVA15 insufflatorMay 2, 2024
K233020tautona group research and development, coTauTona Pneumoperitoneum Assist Device (TPAD)January 12, 2024
K232401hangzhou kangji medical instrument coDisposable Veress NeedlesDecember 14, 2023
K230239conmed corporationAirSeal iFS System; AirSeal dV SolutionSeptember 20, 2023
K231342guangdong optomedic technologiesInsufflator (OPTO-IFL1000)September 20, 2023
K231407premium medical technologyStarFinAugust 29, 2023
K222812scivita medical technology coInsufflatorMay 16, 2023
K221995surgnova healthcare technologies (zhejiang) coGas InsufflatorMarch 28, 2023
K222901palliareEVA15 insufflatorJanuary 27, 2023
K212786core access surgical technologiesLevaLap Laparoscopic Access DeviceFebruary 23, 2022
K211104conmed corporationAirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered TubeAugust 19, 2021
K202799palliareEVA15October 21, 2020
K201361w.o.m. world of medicinePNEUMOCLEARJuly 29, 2020
K193520palliareEVA 15 InsufflatorJuly 23, 2020
K193339guangzhou t.k medical instrument coGTK Veress NeedlesJanuary 30, 2020