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

Decided510(k)Device and applicantCode
Aug 19, 2011K111441UNIMAX VERESS NEEDLE
Unimax Medical Systems, Inc., TW
HIF
May 25, 2011K103692SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
Surgiquest, Inc.
HIF
Sep 27, 2010K102136VESSEL GUARDIAN
Lexion Medical, LLC
HIF
Jun 24, 2010K101320VASOVAPOR
Lexion Medical, LLC
HIF
Sep 25, 2009K090652ALPHA DUO LAP INSUFFLATOR
Hippokratec GmbH, DE
HIF
Sep 3, 2009K091366INSUFLOW DEWHEART
Lexion Medical, LLC
HIF
Aug 26, 2009K090456INSUFLOW
Lexion Medical, LLC
HIF
Mar 30, 2009K080852KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
KARL STORZ Endoscopy-America, Inc.
HIF
Jan 25, 2008K072753REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
Rg Medical USA
HIF
Jan 11, 2008K073452MODIFICATION TO: ARAGON SURGICAL LAPCAP
Aragon Surgical, Inc.
HIF
Dec 13, 2007K070783SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
Sopro
HIF
May 30, 2007K070651ARAGON SURGICAL LAPCAP
Aragon Surgical, Inc.
HIF
May 23, 2007K06336745L CORE INSUFFLATOR, MODEL F114
W.O.M. World of Medicine AG
HIF
Jan 10, 2007K063546INSUFLOW DEVICE, MODEL 6198
Lexion Medical, LLC
HIF
Jul 21, 2006K061387VERESURE BELL
Veresure, Inc.
HIF
May 25, 2006K06072340 L HIGH FLOW INSUFFLATOR F113
W.O.M. World of Medicine AG
HIF
Feb 8, 2006K052125CARBONAID GAS DIFFUSER
Cardia Innovation AB
HIF
Sep 28, 2004K041560FLO-ASSISTANT
Northgate Technologies, Inc.
HIF
Jul 29, 2004K033614MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
Northgate Technologies, Inc.
HIF
Feb 5, 2004K03083740 L HIGH FLOW INSUFFLATOR F108
W.O.M. World of Medicine AG
HIF
Jan 22, 2004K033991MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET
Pall Medical
HIF
Jun 27, 2003K031014HI-FLO THERME PNEU 45, WISAP #7083, 7083V
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh, DE
HIF
May 9, 2003K030469LAPAROSHIELD CONDITIONED INSUFFLATION SET
Pall Medical
HIF
Jan 24, 2003K02205240LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
Northgate Technologies, Inc.
HIF
Nov 8, 2002K021247PNEUMOPERITONEUM INSUFFLATION NEEDLE
Mectra Labs, Inc.
HIF
Sep 19, 2002K022318VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES
Vomed Volzer Medizintechnik GmbH & Co., NL
HIF
Jun 25, 2002K014166UHI-3 HIGH FLOW INSUFFLATION UNIT
Olympus Optical Co., Ltd.
HIF
Apr 2, 2002K011510MULTI HI-FLO PNEU, WISAP #7080
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh, DE
HIF
Oct 23, 2001K010053HUMI-FLOW, MODEL 6-850-00/ 01/02
Northgate Technologies, Inc.
HIF
Aug 27, 2001K002328SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR
Richard Wolf Medical Instruments Corp.
HIF
Mar 2, 2001K000180TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
Richard Wolf Medical Instruments Corp.
HIF
Feb 22, 2001K003703TAUT-INSUFFLATION NEEDLE
Taut, Inc.
HIF
Feb 21, 2001K003792STRYKER HEATED INSUFFLATOR TUBE SET
Stryker Corp.
HIF
Jul 31, 2000K001533SURGIFLATOR-40
W.O.M. Gmhb
HIF
Jun 20, 2000K993625INSUFFLATION NEEDLE- 120MM, MODEL 900-200
Genicon, LC
HIF
Jun 14, 2000K001068NBS CONNECTING TUBE SET
Nbs Products CO
HIF
Apr 3, 2000K000027INSUFFLATION NEEDLE, MODEL R65-933
A & A Medical, Inc.
HIF
Nov 23, 1999K991906LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT
Richard Wolf Medical Instruments Corp.
HIF
Sep 24, 1999K990662DISPOSABLE HEATING TUBING SET #7642HSES
Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh, DE
HIF
Sep 17, 1999K992381CO2 GAS WARMER II, MODEL 6-800-00
Northgate Technologies, Inc.
HIF
Feb 5, 1999K983326OMNIFLATOR 7640 MODEL 7-640-00
Northgate Technologies, Inc.
HIF
Feb 3, 1999K983925ENDOPATH ULTRA VERESS NEEDLE
Ethicon Endo-Surgery, Inc.
HIF
Sep 30, 1998K973447OMNIFLATOR 6630(6-630-00)
Northgate Technologies, Inc.
HIF
Sep 30, 1998K972675CO2 GAS WARMING UNIT (6-800-00)
Northgate Technologies, Inc.
HIF
Sep 10, 1998K981334LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)
Richard Wolf Medical Instruments Corp.
HIF
Jun 26, 1998K981859SURGIFLATOR-20 ECU
W.O.M. World of Medicine GmbH
HIF
Apr 15, 1998K980134KSEA N2O ENDOFLATOR
KARL STORZ Endoscopy-America, Inc.
HIF
Jan 23, 1998K970866FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER
Georgia Biomedical, Inc.
HIF
Dec 9, 1997K973432SURGIFLATOR-30
W.O.M. World of Medicine GmbH, DE
HIF
Aug 6, 1997K955477HI-TEC CO2 INSUFFLATOR TYPE 1300
Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz, DE
HIF

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