FDA 510(k) Applications for Medical Device Product Code "HIF"
(Insufflator, Laparoscopic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K000027 | A & A MEDICAL, INC. | INSUFFLATION NEEDLE, MODEL R65-933 | 04/03/2000 |
| K070651 | ARAGON SURGICAL INC. | ARAGON SURGICAL LAPCAP | 05/30/2007 |
| K073452 | ARAGON SURGICAL INC. | MODIFICATION TO: ARAGON SURGICAL LAPCAP | 01/11/2008 |
| K171139 | Buffalo Filter, LLC | LaparoLight Veress Needle | 05/18/2017 |
| K112975 | CARDIA INNOVATION AB | CARBONAID C02 DIFFUSER | 06/22/2012 |
| K052125 | CARDIA INNOVATION AB | CARBONAID GAS DIFFUSER | 02/08/2006 |
| K190303 | ConMed Corporation | AirSeal | 03/28/2019 |
| K230239 | CONMED Corporation | AirSeal iFS System; AirSeal dV Solution | 09/20/2023 |
| K211104 | ConMed Corporation | AirSeal« dV Solution- AirSeal« Cannula Cap and AirSeal« Bifurcated Filtered Tube Set | 08/19/2021 |
| K172516 | ConMed Corporation | SurgiQuest AIRSEAL iFS System | 03/16/2018 |
| K212786 | Core Access Surgical Technologies, Inc. | LevaLap Laparoscopic Access Device | 02/23/2022 |
| K962683 | DEKNATEL, INC. | SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR | 01/10/1997 |
| K983925 | ETHICON ENDO-SURGERY, INC. | ENDOPATH ULTRA VERESS NEEDLE | 02/03/1999 |
| K162582 | FISHER & PAYKEL HEALTHCARE | HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit | 06/23/2017 |
| K993625 | GENICON, LC | INSUFFLATION NEEDLE- 120MM, MODEL 900-200 | 06/20/2000 |
| K970866 | GEORGIA BIOMEDICAL, INC. | FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER | 01/23/1998 |
| K172835 | GRI Medical and Electronic Technology Co., Ltd. | GRI-Alleset Veress Needle | 06/11/2018 |
| K231342 | Guangdong OptoMedic Technologies, Inc. | Insufflator (OPTO-IFL1000) | 09/20/2023 |
| K193339 | Guangzhou T.K Medical Instrument Co., Ltd. | GTK Veress Needles | 01/30/2020 |
| K142700 | GYNETECH PTY. LTD. | InsufflatOR Needle | 12/19/2014 |
| K955477 | HI TEC MEDICAL VERTRIEBS-GMBH FUR INNOVATIVE MEDIZ | HI-TEC CO2 INSUFFLATOR TYPE 1300 | 08/06/1997 |
| K090652 | HIPPOKRATEC GMBH | ALPHA DUO LAP INSUFFLATOR | 09/25/2009 |
| K963423 | KARL STORZ ENDOSCOPY | KSEA CO2 ENDOFLATOR | 05/27/1997 |
| K161554 | KARL STORZ ENDOSCOPY-AMERICA, INC. | ENDOFLATOR 40, ENDOFLATOR 50 | 03/02/2017 |
| K962863 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR | 11/19/1996 |
| K080852 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1 | 03/30/2009 |
| K980134 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA N2O ENDOFLATOR | 04/15/1998 |
| K955073 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA THERMOFLATOR (MODEL 26 4320 20) | 12/06/1996 |
| K170799 | LEXION Medical LLC | AP 50/30 Insufflator with Insuflow Port | 11/14/2017 |
| K191780 | Lexion Medical LLC | AP50/30 Insufflator with Insuflow Port | 08/28/2019 |
| K090456 | LEXION MEDICAL, LLC. | INSUFLOW | 08/26/2009 |
| K063546 | LEXION MEDICAL, LLC. | INSUFLOW DEVICE, MODEL 6198 | 01/10/2007 |
| K091366 | LEXION MEDICAL, LLC. | INSUFLOW DEWHEART | 09/03/2009 |
| K120640 | LEXION MEDICAL, LLC. | INSUFLOW SYNERGY PORT | 07/18/2012 |
| K140263 | LEXION MEDICAL, LLC. | INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT | 03/05/2014 |
| K132204 | LEXION MEDICAL, LLC. | INSUFLOW SYNERGY XL PORT | 08/22/2013 |
| K132203 | LEXION MEDICAL, LLC. | PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA | 09/20/2013 |
| K101320 | LEXION MEDICAL, LLC. | VASOVAPOR | 06/24/2010 |
| K102136 | LEXION MEDICAL, LLC. | VESSEL GUARDIAN | 09/27/2010 |
| K112357 | LEXION MEDICAL, LLC. | VESSEL GUARDIAN | 11/10/2011 |
| K021247 | MECTRA LABS, INC. | PNEUMOPERITONEUM INSUFFLATION NEEDLE | 11/08/2002 |
| K111955 | MEDLINE, INDUSTRIES, INC. | MEDLINE PNEUMOPERITONEUM NEEDLE | 11/16/2011 |
| K001068 | NBS PRODUCTS CO | NBS CONNECTING TUBE SET | 06/14/2000 |
| K120151 | NORTHGATE TECHNOLOGIES INC. | NEBULAE I | 08/17/2012 |
| K022052 | NORTHGATE TECHNOLOGIES, INC. | 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 | 01/24/2003 |
| K992381 | NORTHGATE TECHNOLOGIES, INC. | CO2 GAS WARMER II, MODEL 6-800-00 | 09/17/1999 |
| K972675 | NORTHGATE TECHNOLOGIES, INC. | CO2 GAS WARMING UNIT (6-800-00) | 09/30/1998 |
| K041560 | NORTHGATE TECHNOLOGIES, INC. | FLO-ASSISTANT | 09/28/2004 |
| K010053 | NORTHGATE TECHNOLOGIES, INC. | HUMI-FLOW, MODEL 6-850-00/ 01/02 | 10/23/2001 |
| K033614 | NORTHGATE TECHNOLOGIES, INC. | MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 | 07/29/2004 |
| K973447 | NORTHGATE TECHNOLOGIES, INC. | OMNIFLATOR 6630(6-630-00) | 09/30/1998 |
| K983326 | NORTHGATE TECHNOLOGIES, INC. | OMNIFLATOR 7640 MODEL 7-640-00 | 02/05/1999 |
| K122180 | OLYMPUS MEDICAL SYSTEMS CORPORATION | HIGH FLOW INSUFFLANTION UNIT | 11/13/2012 |
| K110294 | OLYMPUS MEDICAL SYSTEMS CORPORATION | HIGH FLOW INSUFFLATION UNIT UHI-4 | 11/18/2011 |
| K014166 | OLYMPUS OPTICAL CO., LTD. | UHI-3 HIGH FLOW INSUFFLATION UNIT | 06/25/2002 |
| K030469 | PALL MEDICAL | LAPAROSHIELD CONDITIONED INSUFFLATION SET | 05/09/2003 |
| K033991 | PALL MEDICAL | MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET | 01/22/2004 |
| K193520 | Palliare Ltd. | EVA 15 Insufflator | 07/23/2020 |
| K202799 | Palliare Ltd. | EVA15 | 10/21/2020 |
| K222901 | Palliare Ltd. | EVA15 insufflator | 01/27/2023 |
| K231407 | Premium Medical Technology LLC | StarFin | 08/29/2023 |
| K072753 | RG MEDICAL USA | REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES | 01/25/2008 |
| K981334 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | LAPARO CO2-PNEU (AND WITH VIDEO MONITORING) | 09/10/1998 |
| K991906 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT | 11/23/1999 |
| K002328 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR | 08/27/2001 |
| K000180 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP | 03/02/2001 |
| K222812 | Scivita Medical Technology Co., Ltd. | Insufflator | 05/16/2023 |
| K070783 | SOPRO | SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR | 12/13/2007 |
| K153367 | SOPRO - ACTEON GROUP | S698 Symbioz flow | 06/17/2016 |
| K003792 | STRYKER CORP. | STRYKER HEATED INSUFFLATOR TUBE SET | 02/21/2001 |
| K955393 | SURGICAL INNOVATIONS PLC | NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE | 01/09/1997 |
| K121336 | SURGIQUEST, INC. | MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 | 07/03/2012 |
| K103692 | SURGIQUEST, INC. | SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 | 05/25/2011 |
| K143404 | SURGIQUEST, INC. | SurgiQuest AirSeal iFS System | 03/20/2015 |
| K221995 | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Gas Insufflator | 03/28/2023 |
| K003703 | TAUT, INC. | TAUT-INSUFFLATION NEEDLE | 02/22/2001 |
| K173545 | TEMED | TEMED Gas Diffuser | 02/14/2018 |
| K162648 | TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. | U-Blade Veress Needle | 12/12/2016 |
| K111441 | UNIMAX MEDICAL SYSTEMS, INC. | UNIMAX VERESS NEEDLE | 08/19/2011 |
| K150068 | Unimicro Medical Systems (ShenZhen) Co.,Ltd. | Unimicro Veress Needle | 07/31/2015 |
| K061387 | VERESURE, INC. | VERESURE BELL | 07/21/2006 |
| K022318 | VOMED VOLZER MEDIZINTECHNIK GMBH & CO. | VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES | 09/19/2002 |
| K153513 | W.O.M WORLD OF MEDICINE GMBH | Insufflator 50L FM134 | 03/04/2016 |
| K170784 | W.O.M World Of Medicine GmbH | PNEUMOCLEAR | 05/15/2017 |
| K950035 | W.O.M. GMBH | SURGIFLATOR 20 | 02/12/1996 |
| K001533 | W.O.M. GMHB | SURGIFLATOR-40 | 07/31/2000 |
| K030837 | W.O.M. WORLD OF MEDICINE AG | 40 L HIGH FLOW INSUFFLATOR F108 | 02/05/2004 |
| K060723 | W.O.M. WORLD OF MEDICINE AG | 40 L HIGH FLOW INSUFFLATOR F113 | 05/25/2006 |
| K063367 | W.O.M. WORLD OF MEDICINE AG | 45L CORE INSUFFLATOR, MODEL F114 | 05/23/2007 |
| K201361 | W.O.M. WORLD OF MEDICINE GmbH | PNEUMOCLEAR | 07/29/2020 |
| K981859 | W.O.M. WORLD OF MEDICINE, GMBH | SURGIFLATOR-20 ECU | 06/26/1998 |
| K955791 | W.O.M. WORLD OF MEDICINE, GMBH | SURGIFLATOR-20 PIM | 12/17/1996 |
| K973432 | W.O.M. WORLD OF MEDICINE, GMBH | SURGIFLATOR-30 | 12/09/1997 |
| K990662 | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH | DISPOSABLE HEATING TUBING SET #7642HSES | 09/24/1999 |
| K031014 | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH | HI-FLO THERME PNEU 45, WISAP #7083, 7083V | 06/27/2003 |
| K011510 | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH | MULTI HI-FLO PNEU, WISAP #7080 | 04/02/2002 |
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