Insufflator, Laparoscopic
FDA product code HIF · Class II (moderate risk) · 21 CFR 884.1730 · Obstetrics/Gynecology
179510(k) clearances
0PMA approvals
28recalls
Manufacturers
- Northgate Technologies, Inc. 16
- Lexion Medical, LLC 12
- W.O.M. World of Medicine GmbH 10
- KARL STORZ Endoscopy-America, Inc. 9
- Richard Wolf Medical Instruments Corp. 7
- Conmed Corporation 4
- Palliare , Ltd. 4
- Mectra Labs, Inc. 3
- Medline Industries, LP 3
- Surgiquest, Inc. 3
- Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh 3
- Olympus Medical Systems Corp. 3
- Snowden-Pencer 3
- Aragon Surgical, Inc. 2
- Cabot Medical Corp. 2
- Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz 2
- Kli 2
- Dexide, Inc. 2
- Cardia Innovation AB 2
- Andronic Devices, Ltd. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260209 | ENDOFLATOR+; Smart Smoke EvacuationHIF · Traditional | Karl Storz SE & CO. KG | 08/19/2026SE |
| K252584 | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)HIF · Traditional | Weyo Surgical Technology , Ltd. | 06/25/2026SE |
| K252318 | Insufflator (OPTO-IFL1000)HIF · Traditional | Guangdong Optomedic Technologies, Inc. | 04/16/2026SE |
| K250388 | Endoflator +HIF · Traditional | Karl Storz SE & CO. KG | 09/22/2025SE |
| K242772 | AirSurgN Insufflator (10030/AirSurgN)HIF · Traditional | SmartsurgN, Inc. | 04/11/2025SE |
| K243527 | High Flow Insufflation Unit (UHI-4)HIF · Traditional | Olympus Medical Systems Corporation | 01/13/2025SE |
| K242536 | TauTona Pneumoperitoneum Assist Device (TPAD)HIF · Traditional | Tautona Group | 10/15/2024SE |
| K232902 | EVA15 insufflatorHIF · Traditional | Palliare , Ltd. | 05/02/2024SE |
| K232464 | VereSee Optical Veres Needle SystemHIF · Traditional | Freyja Healthcare, LLC | 05/02/2024SE |
| K233020 | TauTona Pneumoperitoneum Assist Device (TPAD)HIF · Traditional | Tautona Group Research & Development, Co., LLC | 01/12/2024SE |
| K232401 | Disposable Veress NeedlesHIF · Traditional | Hangzhou Kangji Medical Instrument Co., Ltd. | 12/14/2023SE |
| K231342 | Insufflator (OPTO-IFL1000)HIF · Traditional | Guangdong Optomedic Technologies, Inc. | 09/20/2023SE |
| K230239 | AirSeal iFS System; AirSeal dV SolutionHIF · Traditional | Conmed Corporation | 09/20/2023SE |
| K231407 | StarFinHIF · Traditional | Premium Medical Technology, LLC | 08/29/2023SE |
| K222812 | InsufflatorHIF · Traditional | Scivita Medical Technology Co., Ltd. | 05/16/2023SE |
| K221995 | Gas InsufflatorHIF · Traditional | Surgnova Healthcare Technologies (Zhejiang) Co.… | 03/28/2023SE |
| K222901 | EVA15 insufflatorHIF · Traditional | Palliare , Ltd. | 01/27/2023SE |
| K212786 | LevaLap Laparoscopic Access DeviceHIF · Traditional | Core Access Surgical Technologies, Inc. | 02/23/2022SE |
| K211104 | AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube SetHIF · Traditional | Conmed Corporation | 08/19/2021SE |
| K202799 | EVA15HIF · Special | Palliare , Ltd. | 10/21/2020SE |
| K201361 | PneumoclearHIF · Traditional | W.O.M. World of Medicine GmbH | 07/29/2020SE |
| K193520 | EVA 15 InsufflatorHIF · Traditional | Palliare , Ltd. | 07/23/2020SE |
| K193339 | GTK Veress NeedlesHIF · Traditional | Guangzhou T.K Medical Instrument Co., Ltd. | 01/30/2020SE |
| K191780 | AP50/30 Insufflator with Insuflow PortHIF · Traditional | Lexion Medical, LLC | 08/28/2019SE |
| K190303 | AirSealHIF · Traditional | Conmed Corporation | 03/28/2019SE |
| K172835 | GRI-Alleset Veress NeedleHIF · Traditional | Gri Medical and Electronic Technology Co., Ltd. | 06/11/2018SE |
| K172516 | SurgiQuest AIRSEAL iFS SystemHIF · Traditional | Conmed Corporation | 03/16/2018SE |
| K173545 | TEMED Gas DiffuserHIF · Traditional | Temed | 02/14/2018SE |
| K170799 | AP 50/30 Insufflator with Insuflow PortHIF · Traditional | Lexion Medical, LLC | 11/14/2017SE |
| K162582 | HumiGard Surgical Humidification System, HumiGard Humdified Insufflation KitHIF · Traditional | Fisher & Paykel Healthcare | 06/23/2017SE |
| K171139 | LaparoLight Veress NeedleHIF · Traditional | Buffalo Filter, LLC | 05/18/2017SE |
| K170784 | PneumoclearHIF · Traditional | W.O.M. World of Medicine GmbH | 05/15/2017SE |
| K161554 | Endoflator 40, Endoflator 50HIF · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/02/2017SE |
| K162648 | U-Blade Veress NeedleHIF · Traditional | Tianjin Uwell Medical Device Manufacturing Co.… | 12/12/2016SE |
| K153367 | S698 Symbioz flowHIF · Traditional | Sopro - Acteon Group | 06/17/2016SE |
| K153513 | Insufflator 50L FM134HIF · Traditional | W.O.M. World of Medicine GmbH | 03/04/2016SE |
| K150068 | Unimicro Veress NeedleHIF · Traditional | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 07/31/2015SE |
| K143404 | SurgiQuest AirSeal iFS SystemHIF · Traditional | Surgiquest, Inc. | 03/20/2015SE |
| K142700 | InsufflatOR NeedleHIF · Traditional | Gynetech Pty. , Ltd. | 12/19/2014SE |
| K140263 | Insuflow Synergy Port, Insuflow Synergy XL PortHIF · Special | Lexion Medical, LLC | 03/05/2014SE |
| K132203 | Pneuview Xe Veryclear Gas Evacuation CannulaHIF · Traditional | Lexion Medical, LLC | 09/20/2013SE |
| K132204 | Insuflow Synergy XL PortHIF · Special | Lexion Medical, LLC | 08/22/2013SE |
| K122180 | High Flow Insufflantion UnitHIF · Traditional | Olympus Medical Systems Corporation | 11/13/2012SE |
| K120151 | Nebulae IHIF · Traditional | Northgate Technologies, Inc. | 08/17/2012SE |
| K120640 | Insuflow Synergy PortHIF · Traditional | Lexion Medical, LLC | 07/18/2012SE |
| K121336 | Modified Surgiquest Airseal Optical Trocar & Cannula System with Integrated Insufflator…HIF · Special | Surgiquest, Inc. | 07/03/2012SE |
| K112975 | Carbonaid C02 DiffuserHIF · Traditional | Cardia Innovation AB | 06/22/2012SE |
| K110294 | High Flow Insufflation Unit UHI-4HIF · Traditional | Olympus Medical Systems Corporation | 11/18/2011SE |
| K111955 | Medline Pneumoperitoneum NeedleHIF · Traditional | Medline Industries, Inc. | 11/16/2011SE |
| K112357 | Vessel GuardianHIF · Traditional | Lexion Medical, LLC | 11/10/2011SE |
| K111441 | Unimax Veress NeedleHIF · Traditional | Unimax Medical Systems, Inc. | 08/19/2011SE |
| K103692 | Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000HIF · Traditional | Surgiquest, Inc. | 05/25/2011SE |
| K102136 | Vessel GuardianHIF · Traditional | Lexion Medical, LLC | 09/27/2010SE |
| K101320 | VasovaporHIF · Traditional | Lexion Medical, LLC | 06/24/2010SE |
| K090652 | Alpha Duo Lap InsufflatorHIF · Traditional | Hippokratec GmbH | 09/25/2009SE |
| K091366 | Insuflow DewheartHIF · Traditional | Lexion Medical, LLC | 09/03/2009SE |
| K090456 | InsuflowHIF · Traditional | Lexion Medical, LLC | 08/26/2009SE |
| K080852 | Ksea Electronic CO2 Endoflator LC, Model 26430320-1HIF · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/30/2009SE |
| K072753 | Reusable, Disposable Laparoscopic Instrument and Surgical Device and AccessoriesHIF · Traditional | Rg Medical USA | 01/25/2008SE |
| K073452 | Modification to: Aragon Surgical LapcapHIF · Special | Aragon Surgical, Inc. | 01/11/2008SE |
| K070783 | Sopro Model 640 Laparoscopic InsufflatorHIF · Traditional | Sopro | 12/13/2007SE |
| K070651 | Aragon Surgical LapcapHIF · Traditional | Aragon Surgical, Inc. | 05/30/2007SE |
| K063367 | 45L Core Insufflator, Model F114HIF · Traditional | W.O.M. World of Medicine AG | 05/23/2007SE |
| K063546 | Insuflow Device, Model 6198HIF · Special | Lexion Medical, LLC | 01/10/2007SE |
| K061387 | Veresure BellHIF · Traditional | Veresure, Inc. | 07/21/2006SE |
| K060723 | 40 L High Flow Insufflator F113HIF · Traditional | W.O.M. World of Medicine AG | 05/25/2006SE |
| K052125 | Carbonaid Gas DiffuserHIF · Traditional | Cardia Innovation AB | 02/08/2006SE |
| K041560 | Flo-AssistantHIF · Traditional | Northgate Technologies, Inc. | 09/28/2004SE |
| K033614 | Mistic Humidification System 850-00/01/02, 2215HIF · Traditional | Northgate Technologies, Inc. | 07/29/2004SE |
| K030837 | 40 L High Flow Insufflator F108HIF · Traditional | W.O.M. World of Medicine AG | 02/05/2004SE |
| K033991 | Modification to Laparoshield Conditioned Insufflation SetHIF · Special | Pall Medical | 01/22/2004SE |
| K031014 | Hi-Flo Therme Pneu 45, Wisap #7083, 7083VHIF · Traditional | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 06/27/2003SE |
| K030469 | Laparoshield Conditioned Insufflation SetHIF · Traditional | Pall Medical | 05/09/2003SE |
| K022052 | 40LPM Abdominal Insufflator, Catalog # 72-00203-0HIF · Traditional | Northgate Technologies, Inc. | 01/24/2003SE |
| K021247 | Pneumoperitoneum Insufflation NeedleHIF · Traditional | Mectra Labs, Inc. | 11/08/2002SE |
| K022318 | Vomed Endoscopic and Urological AccessoriesHIF · Traditional | Vomed Volzer Medizintechnik GmbH & Co. | 09/19/2002SE |
| K014166 | UHI-3 High Flow Insufflation UnitHIF · Traditional | Olympus Optical Co., Ltd. | 06/25/2002SE |
| K011510 | Multi Hi-Flo Pneu, Wisap #7080HIF · Traditional | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 04/02/2002SE |
| K010053 | Humi-Flow, Model 6-850-00/ 01/02HIF · Traditional | Northgate Technologies, Inc. | 10/23/2001SE |
| K002328 | Sios-Interface for Auto Light Projector, Sios-Interface for 3 CCD Endocam…HIF · Traditional | Richard Wolf Medical Instruments Corp. | 08/27/2001SE |
| K000180 | Transanal Endoscopic Microsurgery (Tem) Combination System and Instrument Set…HIF · Traditional | Richard Wolf Medical Instruments Corp. | 03/02/2001SE |
| K003703 | Taut-Insufflation NeedleHIF · Traditional | Taut, Inc. | 02/22/2001SE |
| K003792 | Stryker Heated Insufflator Tube SetHIF · Traditional | Stryker Corp. | 02/21/2001SE |
| K001533 | SURGIFLATOR-40HIF · Special | W.O.M. Gmhb | 07/31/2000SE |
| K993625 | Insufflation Needle- 120MM, Model 900-200HIF · Traditional | Genicon, LC | 06/20/2000SE |
| K001068 | NBS Connecting Tube SetHIF · Traditional | Nbs Products CO | 06/14/2000SE |
| K000027 | Insufflation Needle, Model R65-933HIF · Traditional | A & A Medical, Inc. | 04/03/2000SE |
| K991906 | Laparo CO2-PNEU Automatic Insufflator with 30L Flow Rate,And Video-Screen Display, High…HIF · Traditional | Richard Wolf Medical Instruments Corp. | 11/23/1999SE |
| K990662 | Disposable Heating Tubing Set #7642HSESHIF · Traditional | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 09/24/1999SE |
| K992381 | CO2 Gas Warmer II, Model 6-800-00HIF · Special | Northgate Technologies, Inc. | 09/17/1999SE |
| K983326 | Omniflator 7640 Model 7-640-00HIF · Traditional | Northgate Technologies, Inc. | 02/05/1999SE |
| K983925 | Endopath Ultra Veress NeedleHIF · Traditional | Ethicon Endo-Surgery, Inc. | 02/03/1999SE |
| K973447 | Omniflator 6630(6-630-00)HIF · Traditional | Northgate Technologies, Inc. | 09/30/1998SE |
| K972675 | CO2 Gas Warming Unit (6-800-00)HIF · Traditional | Northgate Technologies, Inc. | 09/30/1998SE |
| K981334 | Laparo CO2-PNEU (and with Video Monitoring)HIF · Traditional | Richard Wolf Medical Instruments Corp. | 09/10/1998SE |
| K981859 | SURGIFLATOR-20 EcuHIF · Special | W.O.M. World of Medicine GmbH | 06/26/1998SE |
| K980134 | Ksea N2O EndoflatorHIF · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/15/1998SE |
| K970866 | Filter Heater/Hydrator Insufflation Gas ConditionerHIF · Traditional | Georgia Biomedical, Inc. | 01/23/1998SE |
| K973432 | SURGIFLATOR-30HIF · Traditional | W.O.M. World of Medicine GmbH | 12/09/1997SE |
| K955477 | Hi-Tec CO2 Insufflator Type 1300HIF · Traditional | Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz | 08/06/1997SE |
| K963423 | Ksea CO2 EndoflatorHIF · Traditional | Karl Storz Endoscopy | 05/27/1997SE |
| K962683 | Snowden-Pencer Computerized High Flow InsufflatorHIF · Traditional | Deknatel, Inc. | 01/10/1997SE |
| K955393 | Numo NM-1000 Automatic Carbon-Dioxide for EndoscopeHIF · Traditional | Surgical Innovations Plc | 01/09/1997SE |
| K955791 | SURGIFLATOR-20 PimHIF · Traditional | W.O.M. World of Medicine GmbH | 12/17/1996SE |
| K955073 | Ksea Thermoflator (Model 26 4320 20)HIF · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/06/1996SE |
| K962863 | Karl Storz Model 264305-20 Electronic EndoflatorHIF · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/19/1996SE |
| K950035 | Surgiflator 20HIF · Traditional | W.O.M. GmbH | 02/12/1996SE |
| K953162 | Olympus High Flow Insufflation UnitHIF · Traditional | Olympus America, Inc. | 12/19/1995SE |
| K951694 | Electronic LaparoflatorHIF · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/04/1995SE |
| K951961 | Ksea Model 26012CH Electronic LaparoflatorHIF · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/01/1995SE |
| K941438 | Op-Pneu Electronic CO2HIF · Traditional | Wisap/U.S.A. | 05/11/1995SE |
| K930013 | CO2 Insufflator 1100HIF · Traditional | Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz | 04/14/1995SE |
| K950219 | Endolap Insufflator Tubing SetHIF · Traditional | Endolap, Inc. | 03/23/1995SE |
| K934115 | 3000 Electronic Insufflator ModificationHIF · Traditional | Cabot Medical Corp. | 03/15/1995SE |
| K945789 | Deroyal Disposable Insufflation Tubing FilterHIF · Traditional | Deroyal Industries, Inc. | 02/07/1995SE |
| K944509 | Dexide Insufflation Tubing with FilterHIF · Traditional | Dexide, Inc. | 02/07/1995SE |
| K934884 | Model 2231 CO2 InsufflatorHIF · Traditional | Richard Wolf Medical Instruments Corp. | 02/07/1995SE |
| K943954 | Aspen Surgical Systems Insufflation Tubing Set with FilterHIF · Traditional | Conmedcorp | 11/15/1994SE |
| K935862 | Northgate Technologies Omniflator Model 6600HIF · Traditional | Northgate Technologies, Inc. | 08/19/1994SE |
| K942207 | Reflex Ins Insufflation NeedleHIF · Traditional | Richard-Allan Medical | 05/27/1994SE |
| K941685 | Disposable Filtered Insufflation Tubing SetHIF · Traditional | Blue Planet Industries, Inc. | 05/26/1994SE |
| K934928 | Insite Filter & Tubing SetHIF · Traditional | Andronic Devices, Ltd. | 05/26/1994SE |
| K934926 | Insite Model 20 & Model 15 InsufflatorsHIF · Traditional | Andronic Devices, Ltd. | 05/26/1994SE |
| K934114 | Karl Storz Electronic LaparoflatorHIF · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/10/1994SE |
| K934043 | Karl Storz Electronic LaparoflatorHIF · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/10/1994SE |
| K930696 | Sure-Flo Insufflation TubingHIF · Traditional | O.R. Resources, Inc. | 04/19/1994SE |
| K933094 | Insufflator Tubing Kit W/FilterHIF · Traditional | Inman Medical Corp. | 04/18/1994SE |
| K930767 | Insufo-Gard #100-104HIF · Traditional | Acorn Medical, Inc. | 04/18/1994SE |
| K936155 | Adair Insufflation and Instrumentation CannulaHIF · Traditional | Micromedical Devices, Inc. | 04/11/1994SE |
| K921756 | Electronic Insufflator Model 2054.61HIF · Traditional | Richard Wolf Medical Instruments Corp. | 03/28/1994SE |
| K924481 | Insufflation TubingHIF · Traditional | Applied Medical Resources | 03/22/1994SE |
| K922777 | Pressure Tubing and AccessoriesHIF · Traditional | Arbor Technologies, Inc. | 03/22/1994SE |
| K935639 | Insufflation Tubing Sterile and Non-SterileHIF · Traditional | Charles Polo & Co., Inc. | 03/17/1994SE |
| K935503 | Davol Laparoscopic Insufflation Tubing SetHIF · Traditional | Davol, Inc. | 03/07/1994SE |
| K934131 | Deroyal Surgical Disposable Insufflation TubingHIF · Traditional | Deroyal Industries, Inc. | 03/07/1994SE |
| K925558 | InfiltubeHIF · Traditional | Medsurg Industries, Inc. | 03/04/1994SE |
| K930192 | Vci Insuflator Filter W/ TubingHIF · Traditional | Vital Concepts, Inc. | 03/02/1994SE |
| K920205 | Ott Insufflation Filter TubingHIF · Traditional | Georgia Biomedical Research Group, Inc. | 10/25/1993SE |
| K923194 | Insufflator Connecting FilterHIF · Traditional | Procedure Products, Inc. | 10/08/1993SE |
| K922244 | Insufflator Tubing/Filter KitHIF · Traditional | O.R. Concepts, Inc. | 09/24/1993SE |
| K925691 | Insufflation TubingHIF · Traditional | Mectra Labs, Inc. | 09/23/1993SE |
| K922245 | Super-Flow TubingHIF · Traditional | Armm, Inc. | 09/03/1993SE |
| K921837 | Medicam 900 Insufflator with AccessoriesHIF · Traditional | Kirschner Medical Corp. | 02/05/1993SE |
| K922038 | CO2 Insufflation TubingHIF · Traditional | Surgeon Surgical Instrumentation, Inc. | 10/13/1992SE |
| K921264 | SurgiflatorHIF · Traditional | W.O.M. World of Medicine GmbH | 10/09/1992SE |
| K913242 | Microprocessed Controlled LaparoflatorHIF · Traditional | Bryan Corp. | 09/25/1992SE |
| K921963 | Disposable, Filtered Insufflation Tubing, 92-900HIF · Traditional | Sun Medical, Inc. | 09/11/1992SE |
| K920959 | Insufflator, LaparoscopicHIF · Traditional | Mectra Labs, Inc. | 07/13/1992SE |
| K915694 | Meditron Electronic Laparoscopic InsufflatorHIF · Traditional | Medical Devices, Inc. | 06/18/1992SE |
| K920986 | Snowden-Pencer High Flow Insufflator, SP/88-9700HIF · Traditional | Snowden-Pencer | 06/04/1992SE |
| K915051 | Modification Model 7201 InsufflatorHIF · Traditional | Northgate Technologies, Inc. | 06/04/1992SE |
| K920114 | CO2 Insufflator High Flow Electronic InsufflatorHIF · Traditional | Spiess Design, Inc. | 04/06/1992SE |
| K914153 | Ott Insufflator Filter Plus/Tubing SetHIF · Traditional | Marlo Surgical Technology | 04/02/1992SE |
| K913873 | System 3000 Electronic InsufflatorHIF · Traditional | Cabot Medical Corp. | 03/20/1992SE |
| K914201 | Lm- Lap 10 High Flow InsufflatorHIF · Traditional | Leisegang Medical, Inc. | 01/09/1992SE |
| K910983 | IV 1000 Insufflator Rapid FlowHIF · Traditional | M.D. Engineering, Inc. | 12/09/1991SE |
| K914403 | General Use Kit #7-510-20HIF · Traditional | Northgate Technologies, Inc. | 11/27/1991SE |
| K914402 | Recirculation Kit #7-510-18HIF · Traditional | Northgate Technologies, Inc. | 11/27/1991SE |
| K914401 | Universal General Use Kit #7-510-16HIF · Traditional | Northgate Technologies, Inc. | 11/27/1991SE |
| K913979 | Endo I/A Y SetHIF · Traditional | Snowden-Pencer | 11/27/1991SE |
| K914101 | Circon Acmi Cat.# Lap 9900; High Flow InsufflatorHIF · Traditional | Circon Video | 11/22/1991SE |
| K913772 | Pressure GuardHIF · Traditional | Beacon Laboratories, Inc. | 11/19/1991SE |
| K911179 | Verres Needles 5 & 6 InchesHIF · Traditional | Northgate Technologies, Inc. | 11/13/1991SE |
| K913835 | Snowden-Pencer Insufflator Tubing SetHIF · Traditional | Snowden-Pencer | 11/07/1991SE |
| K912044 | Model 700 Laparoscopic Electronic InsufflatorHIF · Traditional | Multigon Industries, Inc. | 06/24/1991SE |
| K911479 | Laparoscopic Insuflation Y TubingHIF · Traditional | United States Endoscopy Group, Inc. | 04/29/1991SE |
| K910883 | Laparoflator Electronic 3509HIF · Traditional | F.M. Wiest USA, Inc. | 03/29/1991SE |
| K905481 | Northgate Technologies Model 7201 InsufflatorHIF · Traditional | Northgate Technologies, Inc. | 03/29/1991SE |
| K905705 | Lap 3501 High Flow InsufflatorHIF · Traditional | Circon Acmi | 02/28/1991SE |
| K905549 | The DartHIF · Traditional | Dexide, Inc. | 02/19/1991SE |
| K905417 | Elmed Pneumomat DigitalHIF · Traditional | Elmed, Inc. | 01/31/1991SE |
| K900808 | Rapid Automatic Pneumoperitoneum-IHIF · Traditional | Trek Medical Products, Inc. | 09/19/1990SE |
| K900878 | Ott Insufflation Filter TubingHIF · Traditional | Gynescope Corp. | 05/07/1990SE |
| K882185 | Electronic Insufflator, Model No. 2054.60HIF · Traditional | Richard Wolf Medical Instruments Corp. | 06/22/1988SE |
| K871928 | Carbon Dioxide Insufflator/Laparo & Hi Flow Laser/HIF · Traditional | Medline Industries, Inc. | 11/23/1987SE |
| K845021 | Medical Dynamics Mcconnell Precision Elec-InsufflaHIF · Traditional | Medline Industries, Inc. | 05/20/1985SE |
| K812200 | InsufflatorHIF · Traditional | Reznik Instruments | 09/29/1981SE |
| K781913 | Insuffalator LaparaoscopicHIF · Traditional | Kli | 12/04/1978SE |
| K772297 | Insufflator, Model G100 & 200HIF · Traditional | Kli | 01/05/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2776-2026 Class II | Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery… | Olympus Corporation of the Americas | 06/16/2026Open, Classified |
| Z-2474-2026 Class II | ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip…Potential for overpressure alerts. | ConMed Corporation | 05/14/2026Open, Classified |
| Z-2473-2026 Class II | ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip…Potential for overpressure alerts. | ConMed Corporation | 05/14/2026Open, Classified |
| Z-2472-2026 Class II | ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip…Potential for overpressure alerts. | ConMed Corporation | 05/14/2026Open, Classified |
| Z-2471-2026 Class II | ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip…Potential for overpressure alerts. | ConMed Corporation | 05/14/2026Open, Classified |
| Z-2470-2026 Class II | ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip…Potential for overpressure alerts. | ConMed Corporation | 05/14/2026Open, Classified |
| Z-2469-2026 Class II | ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip…Potential for overpressure alerts. | ConMed Corporation | 05/14/2026Open, Classified |
| Z-2468-2026 Class II | ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip…Potential for overpressure alerts. | ConMed Corporation | 05/14/2026Open, Classified |
| Z-2467-2026 Class II | ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip…Potential for overpressure alerts. | ConMed Corporation | 05/14/2026Open, Classified |
| Z-2466-2026 Class II | ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog…Potential for overpressure alerts. | ConMed Corporation | 05/14/2026Open, Classified |
| Z-2465-2026 Class II | ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog…Potential for overpressure alerts. | ConMed Corporation | 05/14/2026Open, Classified |
| Z-2464-2026 Class II | ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length.…Potential for overpressure alerts. | ConMed Corporation | 05/14/2026Open, Classified |
| Z-1354-2026 Class I | Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the…Issue with software algorithm which may lead to overpressure events. | Olympus Corporation of the Americas | 01/16/2026Open, Classified |
| Z-1353-2026 Class I | Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the…Issue with software algorithm which may lead to overpressure events. | Olympus Corporation of the Americas | 01/16/2026Open, Classified |
| Z-1352-2026 Class I | Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the…Issue with software algorithm which may lead to overpressure events. | Olympus Corporation of the Americas | 01/16/2026Open, Classified |
| Z-1375-2024 Class II | Insufflation unit, UHI-4.Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4… | Olympus Corporation of the Americas | 09/25/2023Open, Classified |
| Z-0075-2024 Class I | Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during… | Olympus Corporation of the Americas | 09/22/2023Open, Classified |
| Z-1147-2021 Class II | ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage:…An internal tubing component in the flow path was made with incorrect material which was not tested for use… | Northgate Technologies, Inc. | 01/15/2021Terminated |
| Z-2706-2020 Class II | Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination…Tube material of a smaller diameter was used. | Richard Wolf GmbH | 06/05/2020Terminated |
| Z-1728-2019 Class II | Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an…The heated tube sets were consistently leaking and detaching from the cassette. | Stryker Corporation | 03/07/2019Terminated |
| Z-1727-2019 Class II | Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an…The heated tube sets were consistently leaking and detaching from the cassette. | Stryker Corporation | 03/07/2019Terminated |
| Z-1726-2019 Class II | Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High…The heated tube sets were consistently leaking and detaching from the cassette. | Stryker Corporation | 03/07/2019Terminated |
| Z-0508-2019 Class II | PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a…It is possible that the packaging of the product can be damaged by the prongs on the tube set. | WOM World of Medicine AG | 10/22/2018Terminated |
| Z-1868-2018 Class II | RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic…Tube ends may be mixed up. | Richard Wolf GmbH | 03/11/2018Terminated |
| Z-0866-2017 Class II | Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae…Device could cause a patient overpressure situation without any visual or auditory indication or warning | Northgate Technologies, Inc. | 11/21/2016Terminated |
| Z-1566-2016 Class II | PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure…When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source… | Stryker Endoscopy | 03/28/2016Terminated |
| Z-2232-2015 Class II | Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | EXP Pharmaceutical Services Corp | 02/11/2015Terminated |
| Z-1198-2010 | Pnemosure Insufflators, model numbers 620-040-600 and 620-040-610, manufactured by…Unexpected powering down/failure to boot up: A problem with a transistor in the heater/temperature sensor… | Stryker Endoscopy | 12/29/2008Terminated |