ClearanceBrief
Panels › Obstetrics/Gynecology › Product code HIF · Class 2

Insufflator, Laparoscopic

Regulation 884.1730

3510(k)s in 12 months (179 all time)
15recalls in 12 months (29 all time)
28recalls that name a 510(k)
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Top companies in HIF

Company510(k)sRecalls
Northgate Technologies, Inc.162
Conmed Corporation411
Lexion Medical, LLC120
W.O.M. World of Medicine AG100
KARL STORZ Endoscopy-America, Inc.90
Richard Wolf Medical Instruments Corp.71
Olympus Corporation of the Americas06
Palliare , Ltd.40
Stryker Corp.13
Mectra Labs, Inc.30
Decided510(k)Device and applicantCode
Aug 19, 2026K260209ENDOFLATOR+; Smart Smoke Evacuation
Karl Storz SE & CO. KG, DE
HIF
Jun 25, 2026K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)
Weyo Surgical Technology , Ltd., CN
HIF
Apr 16, 2026K252318Insufflator (OPTO-IFL1000)
Guangdong Optomedic Technologies, Inc., CN
HIF
Sep 22, 2025K250388ENDOFLATOR +
Karl Storz SE & CO. KG, DE
HIF
Apr 11, 2025K242772AirSurgN Insufflator (10030/AirSurgN)
SmartsurgN, Inc.
HIF
Jan 13, 2025K243527High Flow Insufflation Unit (UHI-4)
Olympus Medical Systems Corporation, JP
HIF
Oct 15, 2024K242536TauTona Pneumoperitoneum Assist Device (TPAD)
Tautona Group
HIF
May 2, 2024K232902EVA15 insufflator
Palliare , Ltd., IE
HIF
May 2, 2024K232464VereSee Optical Veres Needle System
Freyja Healthcare, LLC
HIF
Jan 12, 2024K233020TauTona Pneumoperitoneum Assist Device (TPAD)
Tautona Group Research & Development, Co., LLC
HIF
Dec 14, 2023K232401Disposable Veress Needles
Hangzhou Kangji Medical Instrument Co., Ltd., CN
HIF
Sep 20, 2023K231342Insufflator (OPTO-IFL1000)
Guangdong Optomedic Technologies, Inc., CN
HIF
Sep 20, 2023K230239AirSeal iFS System; AirSeal dV Solution
Conmed Corporation
HIF
Aug 29, 2023K231407StarFin
Premium Medical Technology, LLC
HIF
May 16, 2023K222812Insufflator
Scivita Medical Technology Co., Ltd., CN
HIF
Mar 28, 2023K221995Gas Insufflator
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., CN
HIF
Jan 27, 2023K222901EVA15 insufflator
Palliare , Ltd., IE
HIF
Feb 23, 2022K212786LevaLap Laparoscopic Access Device
Core Access Surgical Technologies, Inc.
HIF
Aug 19, 2021K211104AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set
Conmed Corporation
HIF
Oct 21, 2020K202799EVA15
Palliare , Ltd., IE
HIF
Jul 29, 2020K201361PNEUMOCLEAR
W.O.M. World of Medicine GmbH, DE
HIF
Jul 23, 2020K193520EVA 15 Insufflator
Palliare , Ltd., IE
HIF
Jan 30, 2020K193339GTK Veress Needles
Guangzhou T.K Medical Instrument Co., Ltd., CN
HIF
Aug 28, 2019K191780AP50/30 Insufflator with Insuflow Port
Lexion Medical, LLC
HIF
Mar 28, 2019K190303AirSeal
Conmed Corporation
HIF
Jun 11, 2018K172835GRI-Alleset Veress Needle
Gri Medical and Electronic Technology Co., Ltd., CN
HIF
Mar 16, 2018K172516SurgiQuest AIRSEAL iFS System
Conmed Corporation
HIF
Feb 14, 2018K173545TEMED Gas Diffuser
Temed, GB
HIF
Nov 14, 2017K170799AP 50/30 Insufflator with Insuflow Port
Lexion Medical, LLC
HIF
Jun 23, 2017K162582HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
Fisher & Paykel Healthcare, NZ
HIF
May 18, 2017K171139LaparoLight Veress Needle
Buffalo Filter, LLC
HIF
May 15, 2017K170784PNEUMOCLEAR
W.O.M. World of Medicine GmbH, DE
HIF
Mar 2, 2017K161554ENDOFLATOR 40, ENDOFLATOR 50
KARL STORZ Endoscopy-America, Inc.
HIF
Dec 12, 2016K162648U-Blade Veress Needle
Tianjin Uwell Medical Device Manufacturing Co., Ltd., CN
HIF
Jun 17, 2016K153367S698 Symbioz flow
Sopro - Acteon Group, FR
HIF
Mar 4, 2016K153513Insufflator 50L FM134
W.O.M. World of Medicine GmbH, DE
HIF
Jul 31, 2015K150068Unimicro Veress Needle
Unimicro Medical Systems (Shenzhen) Co., Ltd., CN
HIF
Mar 20, 2015K143404SurgiQuest AirSeal iFS System
Surgiquest, Inc.
HIF
Dec 19, 2014K142700InsufflatOR Needle
Gynetech Pty. , Ltd., AU
HIF
Mar 5, 2014K140263INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
Lexion Medical, LLC
HIF
Sep 20, 2013K132203PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
Lexion Medical, LLC
HIF
Aug 22, 2013K132204INSUFLOW SYNERGY XL PORT
Lexion Medical, LLC
HIF
Nov 13, 2012K122180HIGH FLOW INSUFFLANTION UNIT
Olympus Medical Systems Corporation
HIF
Aug 17, 2012K120151NEBULAE I
Northgate Technologies, Inc.
HIF
Jul 18, 2012K120640INSUFLOW SYNERGY PORT
Lexion Medical, LLC
HIF
Jul 3, 2012K121336MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
Surgiquest, Inc.
HIF
Jun 22, 2012K112975CARBONAID C02 DIFFUSER
Cardia Innovation AB
HIF
Nov 18, 2011K110294HIGH FLOW INSUFFLATION UNIT UHI-4
Olympus Medical Systems Corporation
HIF
Nov 16, 2011K111955MEDLINE PNEUMOPERITONEUM NEEDLE
Medline Industries, Inc.
HIF
Nov 10, 2011K112357VESSEL GUARDIAN
Lexion Medical, LLC
HIF

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