Insufflator, Laparoscopic
FDA product code HIF · 175 cleared devices
Class 2
Obstetrics/Gynecology
- Regulation
- 21 CFR 884.1730
- Review panel
- OB
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1978-01-05 – 2026-08-19
HIF
2026-08-19
HIF
2026-06-25
Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)
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HIF
2026-04-16
Insufflator (OPTO-IFL1000)
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HIF
2025-09-22
ENDOFLATOR +
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HIF
2025-04-11
AirSurgN Insufflator (10030/AirSurgN)
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HIF
2025-01-13
High Flow Insufflation Unit (UHI-4)
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HIF
2024-10-15
TauTona Pneumoperitoneum Assist Device (TPAD)
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HIF
2024-05-02
EVA15 insufflator
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HIF
2024-05-02
VereSee Optical Veres Needle System
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HIF
2024-01-12
TauTona Pneumoperitoneum Assist Device (TPAD)
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HIF
2023-12-14
Disposable Veress Needles
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HIF
2023-09-20
Insufflator (OPTO-IFL1000)
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HIF
2023-09-20
AirSeal iFS System; AirSeal dV Solution
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HIF
2023-08-29
StarFin
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HIF
2023-05-16
Insufflator
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HIF
2023-03-28
Gas Insufflator
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HIF
2023-01-27
EVA15 insufflator
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HIF
2022-02-23
LevaLap Laparoscopic Access Device
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HIF
2021-08-19
AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set
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HIF
2020-10-21
EVA15
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HIF
2020-07-29
PNEUMOCLEAR
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HIF
2020-07-23
EVA 15 Insufflator
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HIF
2020-01-30
GTK Veress Needles
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HIF
2019-08-28
AP50/30 Insufflator with Insuflow Port
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HIF
2019-03-28
AirSeal
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HIF
2018-06-11
GRI-Alleset Veress Needle
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HIF
2018-03-16
SurgiQuest AIRSEAL iFS System
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HIF
2018-02-14
TEMED Gas Diffuser
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HIF
2017-11-14
AP 50/30 Insufflator with Insuflow Port
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HIF
2017-06-23
HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
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HIF
2017-05-18
LaparoLight Veress Needle
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HIF
2017-05-15
PNEUMOCLEAR
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HIF
2017-03-02
ENDOFLATOR 40, ENDOFLATOR 50
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HIF
2016-12-12
U-Blade Veress Needle
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HIF
2016-06-17
S698 Symbioz flow
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HIF
2016-03-04
Insufflator 50L FM134
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HIF
2013-09-20
PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
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HIF
2013-08-22
INSUFLOW SYNERGY XL PORT
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HIF
2012-11-13
HIGH FLOW INSUFFLANTION UNIT
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HIF
2012-08-17
NEBULAE I
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HIF
2012-07-18
INSUFLOW SYNERGY PORT
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HIF
2012-07-03
MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
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HIF
2012-06-22
CARBONAID C02 DIFFUSER
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HIF
2011-11-18
HIGH FLOW INSUFFLATION UNIT UHI-4
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HIF
2011-11-16
MEDLINE PNEUMOPERITONEUM NEEDLE
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HIF
2011-11-10
VESSEL GUARDIAN
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HIF
2011-08-19
UNIMAX VERESS NEEDLE
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HIF
2011-05-25
SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
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HIF
2010-09-27
VESSEL GUARDIAN
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HIF
2010-06-24
VASOVAPOR
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HIF
2009-09-25
ALPHA DUO LAP INSUFFLATOR
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HIF
2009-09-03
INSUFLOW DEWHEART
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HIF
2009-08-26
INSUFLOW
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HIF
2009-03-30
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
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HIF
2008-01-25
REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
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HIF
2008-01-11
MODIFICATION TO: ARAGON SURGICAL LAPCAP
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HIF
2007-12-13
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
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HIF
2007-05-30
ARAGON SURGICAL LAPCAP
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HIF
2007-05-23
45L CORE INSUFFLATOR, MODEL F114
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HIF
2007-01-10
INSUFLOW DEVICE, MODEL 6198
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HIF
2006-07-21
VERESURE BELL
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HIF
2006-05-25
40 L HIGH FLOW INSUFFLATOR F113
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HIF
2006-02-08
CARBONAID GAS DIFFUSER
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HIF
2004-09-28
FLO-ASSISTANT
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HIF
2004-07-29
MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
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HIF
2004-02-05
40 L HIGH FLOW INSUFFLATOR F108
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HIF
2004-01-22
MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET
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HIF
2003-06-27
HI-FLO THERME PNEU 45, WISAP #7083, 7083V
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HIF
2003-05-09
LAPAROSHIELD CONDITIONED INSUFFLATION SET
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HIF
2003-01-24
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
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HIF
2002-11-08
PNEUMOPERITONEUM INSUFFLATION NEEDLE
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HIF
2002-09-19
VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES
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HIF
2002-06-25
UHI-3 HIGH FLOW INSUFFLATION UNIT
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HIF
2002-04-02
MULTI HI-FLO PNEU, WISAP #7080
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HIF
2001-10-23
HUMI-FLOW, MODEL 6-850-00/ 01/02
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HIF
2001-08-27
SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR
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HIF
2001-03-02
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
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HIF
2001-02-22
TAUT-INSUFFLATION NEEDLE
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HIF
2001-02-21
STRYKER HEATED INSUFFLATOR TUBE SET
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HIF
2000-07-31
SURGIFLATOR-40
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HIF
2000-06-20
INSUFFLATION NEEDLE- 120MM, MODEL 900-200
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HIF
2000-06-14
NBS CONNECTING TUBE SET
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HIF
2000-04-03
INSUFFLATION NEEDLE, MODEL R65-933
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HIF
1999-11-23
LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT
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HIF
1999-09-24
DISPOSABLE HEATING TUBING SET #7642HSES
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HIF
1999-09-17
CO2 GAS WARMER II, MODEL 6-800-00
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HIF
1999-02-05
OMNIFLATOR 7640 MODEL 7-640-00
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HIF
1999-02-03
ENDOPATH ULTRA VERESS NEEDLE
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HIF
1998-09-30
OMNIFLATOR 6630(6-630-00)
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HIF
1998-09-30
CO2 GAS WARMING UNIT (6-800-00)
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HIF
1998-09-10
LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)
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HIF
1998-06-26
SURGIFLATOR-20 ECU
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HIF
1998-04-15
KSEA N2O ENDOFLATOR
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HIF
1998-01-23
FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER
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HIF
1997-12-09
SURGIFLATOR-30
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HIF
1997-08-06
HI-TEC CO2 INSUFFLATOR TYPE 1300
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HIF
1997-05-27
KSEA CO2 ENDOFLATOR
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HIF
1997-01-10
SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
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HIF
1997-01-09
NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
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HIF
1996-12-17
SURGIFLATOR-20 PIM
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