Atlas FDA

HIF

178 FDA 510(k) clearances · Product code

144 daysmedian time to decision
412 days90th percentile
178clearances measured

FDA profile

Official device name
Insufflator, Laparoscopic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1730
Medical specialty
Obstetrics/Gynecology
Adverse events (MAUDE)
2021: 654 · 2022: 667 · 2023: 890 · 2024: 1,483 · 2025: 1,519 · 2026: 1,193
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) (K252584)Weyo Surgical Technology , Ltd.2026-06-25
Insufflator (OPTO-IFL1000) (K252318)Guangdong Optomedic Technologies, Inc.2026-04-16
ENDOFLATOR + (K250388)Karl Storz SE & CO. KG2025-09-22
AirSurgN Insufflator (10030/AirSurgN) (K242772)SmartsurgN, Inc.2025-04-11
High Flow Insufflation Unit (UHI-4) (K243527)Olympus Medical Systems Corporation2025-01-13
TauTona Pneumoperitoneum Assist Device (TPAD) (K242536)Tautona Group2024-10-15
VereSee Optical Veres Needle System (K232464)Freyja Healthcare, LLC2024-05-02
EVA15 insufflator (K232902)Palliare , Ltd.2024-05-02
TauTona Pneumoperitoneum Assist Device (TPAD) (K233020)Tautona Group Research & Development, Co., LLC2024-01-12
Disposable Veress Needles (K232401)Hangzhou Kangji Medical Instrument Co., Ltd.2023-12-14
Insufflator (OPTO-IFL1000) (K231342)Guangdong Optomedic Technologies, Inc.2023-09-20
AirSeal iFS System; AirSeal dV Solution (K230239)Conmed Corporation2023-09-20
StarFin (K231407)Premium Medical Technology, LLC2023-08-29
Insufflator (K222812)Scivita Medical Technology Co., Ltd.2023-05-16
Gas Insufflator (K221995)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.2023-03-28
EVA15 insufflator (K222901)Palliare , Ltd.2023-01-27
LevaLap Laparoscopic Access Device (K212786)Core Access Surgical Technologies, Inc.2022-02-23
AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set (K211104)Conmed Corporation2021-08-19
EVA15 (K202799)Palliare , Ltd.2020-10-21
PNEUMOCLEAR (K201361)W.O.M. World of Medicine GmbH2020-07-29
EVA 15 Insufflator (K193520)Palliare , Ltd.2020-07-23
GTK Veress Needles (K193339)Guangzhou T.K Medical Instrument Co., Ltd.2020-01-30
AP50/30 Insufflator with Insuflow Port (K191780)Lexion Medical, LLC2019-08-28
AirSeal (K190303)Conmed Corporation2019-03-28
GRI-Alleset Veress Needle (K172835)Gri Medical and Electronic Technology Co., Ltd.2018-06-11
SurgiQuest AIRSEAL iFS System (K172516)Conmed Corporation2018-03-16
TEMED Gas Diffuser (K173545)Temed2018-02-14
AP 50/30 Insufflator with Insuflow Port (K170799)Lexion Medical, LLC2017-11-14
HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit (K162582)Fisher & Paykel Healthcare2017-06-23
LaparoLight Veress Needle (K171139)Buffalo Filter, LLC2017-05-18
PNEUMOCLEAR (K170784)W.O.M. World of Medicine GmbH2017-05-15
ENDOFLATOR 40, ENDOFLATOR 50 (K161554)KARL STORZ Endoscopy-America, Inc.2017-03-02
U-Blade Veress Needle (K162648)Tianjin Uwell Medical Device Manufacturing Co., Ltd.2016-12-12
S698 Symbioz flow (K153367)Sopro - Acteon Group2016-06-17
Insufflator 50L FM134 (K153513)W.O.M. World of Medicine GmbH2016-03-04
Unimicro Veress Needle (K150068)Unimicro Medical Systems (Shenzhen) Co., Ltd.2015-07-31
SurgiQuest AirSeal iFS System (K143404)Surgiquest, Inc.2015-03-20
InsufflatOR Needle (K142700)Gynetech Pty. , Ltd.2014-12-19
INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT (K140263)Lexion Medical, LLC2014-03-05
PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA (K132203)Lexion Medical, LLC2013-09-20
INSUFLOW SYNERGY XL PORT (K132204)Lexion Medical, LLC2013-08-22
HIGH FLOW INSUFFLANTION UNIT (K122180)Olympus Medical Systems Corporation2012-11-13
NEBULAE I (K120151)Northgate Technologies, Inc.2012-08-17
INSUFLOW SYNERGY PORT (K120640)Lexion Medical, LLC2012-07-18
MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 (K121336)Surgiquest, Inc.2012-07-03
CARBONAID C02 DIFFUSER (K112975)Cardia Innovation AB2012-06-22
HIGH FLOW INSUFFLATION UNIT UHI-4 (K110294)Olympus Medical Systems Corporation2011-11-18
MEDLINE PNEUMOPERITONEUM NEEDLE (K111955)Medline Industries, Inc.2011-11-16
VESSEL GUARDIAN (K112357)Lexion Medical, LLC2011-11-10
UNIMAX VERESS NEEDLE (K111441)Unimax Medical Systems, Inc.2011-08-19
SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 (K103692)Surgiquest, Inc.2011-05-25
VESSEL GUARDIAN (K102136)Lexion Medical, LLC2010-09-27
VASOVAPOR (K101320)Lexion Medical, LLC2010-06-24
ALPHA DUO LAP INSUFFLATOR (K090652)Hippokratec GmbH2009-09-25
INSUFLOW DEWHEART (K091366)Lexion Medical, LLC2009-09-03
INSUFLOW (K090456)Lexion Medical, LLC2009-08-26
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1 (K080852)KARL STORZ Endoscopy-America, Inc.2009-03-30
REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES (K072753)Rg Medical USA2008-01-25
MODIFICATION TO: ARAGON SURGICAL LAPCAP (K073452)Aragon Surgical, Inc.2008-01-11
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR (K070783)Sopro2007-12-13
ARAGON SURGICAL LAPCAP (K070651)Aragon Surgical, Inc.2007-05-30
45L CORE INSUFFLATOR, MODEL F114 (K063367)W.O.M. World of Medicine AG2007-05-23
INSUFLOW DEVICE, MODEL 6198 (K063546)Lexion Medical, LLC2007-01-10
VERESURE BELL (K061387)Veresure, Inc.2006-07-21
40 L HIGH FLOW INSUFFLATOR F113 (K060723)W.O.M. World of Medicine AG2006-05-25
CARBONAID GAS DIFFUSER (K052125)Cardia Innovation AB2006-02-08
FLO-ASSISTANT (K041560)Northgate Technologies, Inc.2004-09-28
MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 (K033614)Northgate Technologies, Inc.2004-07-29
40 L HIGH FLOW INSUFFLATOR F108 (K030837)W.O.M. World of Medicine AG2004-02-05
MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET (K033991)Pall Medical2004-01-22
HI-FLO THERME PNEU 45, WISAP #7083, 7083V (K031014)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh2003-06-27
LAPAROSHIELD CONDITIONED INSUFFLATION SET (K030469)Pall Medical2003-05-09
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 (K022052)Northgate Technologies, Inc.2003-01-24
PNEUMOPERITONEUM INSUFFLATION NEEDLE (K021247)Mectra Labs, Inc.2002-11-08
VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES (K022318)Vomed Volzer Medizintechnik GmbH & Co.2002-09-19
UHI-3 HIGH FLOW INSUFFLATION UNIT (K014166)Olympus Optical Co., Ltd.2002-06-25
MULTI HI-FLO PNEU, WISAP #7080 (K011510)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh2002-04-02
HUMI-FLOW, MODEL 6-850-00/ 01/02 (K010053)Northgate Technologies, Inc.2001-10-23
SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR (K002328)Richard Wolf Medical Instruments Corp.2001-08-27
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP (K000180)Richard Wolf Medical Instruments Corp.2001-03-02
TAUT-INSUFFLATION NEEDLE (K003703)Taut, Inc.2001-02-22
STRYKER HEATED INSUFFLATOR TUBE SET (K003792)Stryker Corp.2001-02-21
SURGIFLATOR-40 (K001533)W.O.M. Gmhb2000-07-31
INSUFFLATION NEEDLE- 120MM, MODEL 900-200 (K993625)Genicon, LC2000-06-20
NBS CONNECTING TUBE SET (K001068)Nbs Products CO2000-06-14
INSUFFLATION NEEDLE, MODEL R65-933 (K000027)A & A Medical, Inc.2000-04-03
LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT (K991906)Richard Wolf Medical Instruments Corp.1999-11-23
DISPOSABLE HEATING TUBING SET #7642HSES (K990662)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh1999-09-24
CO2 GAS WARMER II, MODEL 6-800-00 (K992381)Northgate Technologies, Inc.1999-09-17
OMNIFLATOR 7640 MODEL 7-640-00 (K983326)Northgate Technologies, Inc.1999-02-05
ENDOPATH ULTRA VERESS NEEDLE (K983925)Ethicon Endo-Surgery, Inc.1999-02-03
OMNIFLATOR 6630(6-630-00) (K973447)Northgate Technologies, Inc.1998-09-30
CO2 GAS WARMING UNIT (6-800-00) (K972675)Northgate Technologies, Inc.1998-09-30
LAPARO CO2-PNEU (AND WITH VIDEO MONITORING) (K981334)Richard Wolf Medical Instruments Corp.1998-09-10
SURGIFLATOR-20 ECU (K981859)W.O.M. World of Medicine GmbH1998-06-26
KSEA N2O ENDOFLATOR (K980134)KARL STORZ Endoscopy-America, Inc.1998-04-15
FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER (K970866)Georgia Biomedical, Inc.1998-01-23
SURGIFLATOR-30 (K973432)W.O.M. World of Medicine GmbH1997-12-09
HI-TEC CO2 INSUFFLATOR TYPE 1300 (K955477)Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz1997-08-06
KSEA CO2 ENDOFLATOR (K963423)Karl Storz Endoscopy1997-05-27
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