Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)2Product Code
- HETLaparoscope, Gynecologic (And Accessories)2Product Code
- HEWCuldoscope (And Accessories)2Product Code
- HEXColposcope (And Colpomicroscope)2Product Code
- HEZEndoscope, Transcervical (Amnioscope)(And Accessories)2Product Code
- HFAAmnioscope, Transabdominal (Fetoscope) (And Accessories)FProduct Code
- HFCAspirator, Endocervical2Product Code
- HFDWasher, Endometrial2Product Code
- HFEBrush, Endometrial2Product Code
- HFFAspirator, Endometrial2Product Code
- HGKEndoscope, Fetal Blood Sampling (And Accessories)2Product Code
- HGWSampler, Blood, Fetal2Product Code
- HHKCurette, Suction, Endometrial (And Accessories)2Product Code
- HIFInsufflator, Laparoscopic2Product Code
- K242536TauTona Pneumoperitoneum Assist Device (TPAD)2Cleared 510(K)
- K232902EVA15 insufflator2Cleared 510(K)
- K232464VereSee Optical Veres Needle System2Cleared 510(K)
- K233020TauTona Pneumoperitoneum Assist Device (TPAD)2Cleared 510(K)
- K232401Disposable Veress Needles2Cleared 510(K)
- K231342Insufflator (OPTO-IFL1000)2Cleared 510(K)
- K230239AirSeal iFS System; AirSeal dV Solution2Cleared 510(K)
- K231407StarFin2Cleared 510(K)
- K222812Insufflator2Cleared 510(K)
- K221995Gas Insufflator2Cleared 510(K)
- K222901EVA15 insufflator2Cleared 510(K)
- K212786LevaLap Laparoscopic Access Device2Cleared 510(K)
- K211104AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set2Cleared 510(K)
- K202799EVA152Cleared 510(K)
- K201361PNEUMOCLEAR2Cleared 510(K)
- K193520EVA 15 Insufflator2Cleared 510(K)
- K193339GTK Veress Needles2Cleared 510(K)
- K191780AP50/30 Insufflator with Insuflow Port2Cleared 510(K)
- K190303AirSeal2Cleared 510(K)
- K172835GRI-Alleset Veress Needle2Cleared 510(K)
- K172516SurgiQuest AIRSEAL iFS System2Cleared 510(K)
- K173545TEMED Gas Diffuser2Cleared 510(K)
- K170799AP 50/30 Insufflator with Insuflow Port2Cleared 510(K)
- K162582HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit2Cleared 510(K)
- K171139LaparoLight Veress Needle2Cleared 510(K)
- K170784PNEUMOCLEAR2Cleared 510(K)
- K161554ENDOFLATOR 40, ENDOFLATOR 502Cleared 510(K)
- K162648U-Blade Veress Needle2Cleared 510(K)
- K153367S698 Symbioz flow2Cleared 510(K)
- K153513Insufflator 50L FM1342Cleared 510(K)
- K150068Unimicro Veress Needle2Cleared 510(K)
- K143404SurgiQuest AirSeal iFS System2Cleared 510(K)
- K142700InsufflatOR Needle2Cleared 510(K)
- K140263INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT2Cleared 510(K)
- K132203PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA2Cleared 510(K)
- K132204INSUFLOW SYNERGY XL PORT2Cleared 510(K)
- K122180HIGH FLOW INSUFFLANTION UNIT2Cleared 510(K)
- K120151NEBULAE I2Cleared 510(K)
- K120640INSUFLOW SYNERGY PORT2Cleared 510(K)
- K121336MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 20002Cleared 510(K)
- K112975CARBONAID C02 DIFFUSER2Cleared 510(K)
- K110294HIGH FLOW INSUFFLATION UNIT UHI-42Cleared 510(K)
- K111955MEDLINE PNEUMOPERITONEUM NEEDLE2Cleared 510(K)
- K112357VESSEL GUARDIAN2Cleared 510(K)
- K111441UNIMAX VERESS NEEDLE2Cleared 510(K)
- K103692SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 20002Cleared 510(K)
- K102136VESSEL GUARDIAN2Cleared 510(K)
- K101320VASOVAPOR2Cleared 510(K)
- K090652ALPHA DUO LAP INSUFFLATOR2Cleared 510(K)
- K091366INSUFLOW DEWHEART2Cleared 510(K)
- K090456INSUFLOW2Cleared 510(K)
- K080852KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-12Cleared 510(K)
- K072753REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES2Cleared 510(K)
- K073452MODIFICATION TO: ARAGON SURGICAL LAPCAP2Cleared 510(K)
- K070783SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR2Cleared 510(K)
- K070651ARAGON SURGICAL LAPCAP2Cleared 510(K)
- K06336745L CORE INSUFFLATOR, MODEL F1142Cleared 510(K)
- K063546INSUFLOW DEVICE, MODEL 61982Cleared 510(K)
- K061387VERESURE BELL2Cleared 510(K)
- K06072340 L HIGH FLOW INSUFFLATOR F1132Cleared 510(K)
- K052125CARBONAID GAS DIFFUSER2Cleared 510(K)
- K041560FLO-ASSISTANT2Cleared 510(K)
- K033614MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 22152Cleared 510(K)
- K03083740 L HIGH FLOW INSUFFLATOR F1082Cleared 510(K)
- K033991MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET2Cleared 510(K)
- K031014HI-FLO THERME PNEU 45, WISAP #7083, 7083V2Cleared 510(K)
- K030469LAPAROSHIELD CONDITIONED INSUFFLATION SET2Cleared 510(K)
- K02205240LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-02Cleared 510(K)
- K021247PNEUMOPERITONEUM INSUFFLATION NEEDLE2Cleared 510(K)
- K022318VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES2Cleared 510(K)
- K014166UHI-3 HIGH FLOW INSUFFLATION UNIT2Cleared 510(K)
- K011510MULTI HI-FLO PNEU, WISAP #70802Cleared 510(K)
- K010053HUMI-FLOW, MODEL 6-850-00/ 01/022Cleared 510(K)
- K002328SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR2Cleared 510(K)
- K000180TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP2Cleared 510(K)
- K003703TAUT-INSUFFLATION NEEDLE2Cleared 510(K)
- K003792STRYKER HEATED INSUFFLATOR TUBE SET2Cleared 510(K)
- K001533SURGIFLATOR-402Cleared 510(K)
- K993625INSUFFLATION NEEDLE- 120MM, MODEL 900-2002Cleared 510(K)
- K001068NBS CONNECTING TUBE SET2Cleared 510(K)
- K000027INSUFFLATION NEEDLE, MODEL R65-9332Cleared 510(K)
- K991906LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT2Cleared 510(K)
- K990662DISPOSABLE HEATING TUBING SET #7642HSES2Cleared 510(K)
- K992381CO2 GAS WARMER II, MODEL 6-800-002Cleared 510(K)
- K983326OMNIFLATOR 7640 MODEL 7-640-002Cleared 510(K)
- K983925ENDOPATH ULTRA VERESS NEEDLE2Cleared 510(K)
- K973447OMNIFLATOR 6630(6-630-00)2Cleared 510(K)
- K972675CO2 GAS WARMING UNIT (6-800-00)2Cleared 510(K)
- K981334LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)2Cleared 510(K)
- K981859SURGIFLATOR-20 ECU2Cleared 510(K)
- K980134KSEA N2O ENDOFLATOR2Cleared 510(K)
- K970866FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER2Cleared 510(K)
- K973432SURGIFLATOR-302Cleared 510(K)
- K955477HI-TEC CO2 INSUFFLATOR TYPE 13002Cleared 510(K)
- K963423KSEA CO2 ENDOFLATOR2Cleared 510(K)
- K962683SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR2Cleared 510(K)
- K955393NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE2Cleared 510(K)
- K955791SURGIFLATOR-20 PIM2Cleared 510(K)
- K955073KSEA THERMOFLATOR (MODEL 26 4320 20)2Cleared 510(K)
- K962863KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR2Cleared 510(K)
- K950035SURGIFLATOR 202Cleared 510(K)
- K953162OLYMPUS HIGH FLOW INSUFFLATION UNIT2Cleared 510(K)
- K951694ELECTRONIC LAPAROFLATOR2Cleared 510(K)
- K951961KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR2Cleared 510(K)
- K941438OP-PNEU ELECTRONIC CO22Cleared 510(K)
- K930013CO2 INSUFFLATOR 11002Cleared 510(K)
- K950219ENDOLAP INSUFFLATOR TUBING SET2Cleared 510(K)
- K9341153000 ELECTRONIC INSUFFLATOR MODIFICATION2Cleared 510(K)
- K945789DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER2Cleared 510(K)
- K944509DEXIDE INSUFFLATION TUBING WITH FILTER2Cleared 510(K)
- K934884MODEL 2231 CO2 INSUFFLATOR2Cleared 510(K)
- K943954ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER2Cleared 510(K)
- K935862NORTHGATE TECHNOLOGIES OMNIFLATOR MODEL 66002Cleared 510(K)
- K942207REFLEX INS INSUFFLATION NEEDLE2Cleared 510(K)
- K941685DISPOSABLE FILTERED INSUFFLATION TUBING SET2Cleared 510(K)
- K934926INSITE MODEL 20 & MODEL 15 INSUFFLATORS2Cleared 510(K)
- K934928INSITE FILTER & TUBING SET2Cleared 510(K)
- K934114KARL STORZ ELECTRONIC LAPAROFLATOR2Cleared 510(K)
- K934043KARL STORZ ELECTRONIC LAPAROFLATOR2Cleared 510(K)
- K930696SURE-FLO INSUFFLATION TUBING2Cleared 510(K)
- K933094INSUFFLATOR TUBING KIT W/FILTER2Cleared 510(K)
- K930767INSUFO-GARD #100-1042Cleared 510(K)
- K936155ADAIR INSUFFLATION AND INSTRUMENTATION CANNULA2Cleared 510(K)
- K921756ELECTRONIC INSUFFLATOR MODEL 2054.612Cleared 510(K)
- K924481INSUFFLATION TUBING2Cleared 510(K)
- K922777PRESSURE TUBING AND ACCESSORIES2Cleared 510(K)
- K935639INSUFFLATION TUBING STERILE AND NON-STERILE2Cleared 510(K)
- K935503DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET2Cleared 510(K)
- K934131DEROYAL SURGICAL DISPOSABLE INSUFFLATION TUBING2Cleared 510(K)
- K925558INFILTUBE2Cleared 510(K)
- K930192VCI INSUFLATOR FILTER W/ TUBING2Cleared 510(K)
- K920205OTT INSUFFLATION FILTER TUBING2Cleared 510(K)
- K923194INSUFFLATOR CONNECTING FILTER2Cleared 510(K)
- K922244INSUFFLATOR TUBING/FILTER KIT2Cleared 510(K)
- K925691INSUFFLATION TUBING2Cleared 510(K)
- K922245SUPER-FLOW TUBING2Cleared 510(K)
- K921837MEDICAM 900 INSUFFLATOR WITH ACCESSORIES2Cleared 510(K)
- K922038CO2 INSUFFLATION TUBING2Cleared 510(K)
- K921264SURGIFLATOR2Cleared 510(K)
- K913242MICROPROCESSED CONTROLLED LAPAROFLATOR2Cleared 510(K)
- K921963DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-9002Cleared 510(K)
- K920959INSUFFLATOR, LAPAROSCOPIC2Cleared 510(K)
- K915694MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR2Cleared 510(K)
- K920986SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-97002Cleared 510(K)
- K915051MODIFICATION MODEL 7201 INSUFFLATOR2Cleared 510(K)
- K920114CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR2Cleared 510(K)
- K914153OTT INSUFFLATOR FILTER PLUS/TUBING SET2Cleared 510(K)
- K913873SYSTEM 3000 ELECTRONIC INSUFFLATOR2Cleared 510(K)
- K914201LM- LAP 10 HIGH FLOW INSUFFLATOR2Cleared 510(K)
- K910983IV 1000 INSUFFLATOR RAPID FLOW2Cleared 510(K)
- K914402RECIRCULATION KIT #7-510-182Cleared 510(K)
- K914403GENERAL USE KIT #7-510-202Cleared 510(K)
- K914401UNIVERSAL GENERAL USE KIT #7-510-162Cleared 510(K)
- K913979ENDO I/A Y SET2Cleared 510(K)
- K914101CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATOR2Cleared 510(K)
- K911179VERRES NEEDLES 5 & 6 INCHES2Cleared 510(K)
- K913835SNOWDEN-PENCER INSUFFLATOR TUBING SET2Cleared 510(K)
- K912044MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR2Cleared 510(K)
- K911479LAPAROSCOPIC INSUFLATION Y TUBING2Cleared 510(K)
- K910883LAPAROFLATOR ELECTRONIC 35092Cleared 510(K)
- K905481NORTHGATE TECHNOLOGIES MODEL 7201 INSUFFLATOR2Cleared 510(K)
- K905705LAP 3501 HIGH FLOW INSUFFLATOR2Cleared 510(K)
- K905549THE DART2Cleared 510(K)
- K905417ELMED PNEUMOMAT DIGITAL2Cleared 510(K)
- K900808RAPID AUTOMATIC PNEUMOPERITONEUM-I2Cleared 510(K)
- K900878OTT INSUFFLATION FILTER TUBING2Cleared 510(K)
- K882185ELECTRONIC INSUFFLATOR, MODEL NO. 2054.602Cleared 510(K)
- K871928CARBON DIOXIDE INSUFFLATOR/LAPARO & HI FLOW LASER/2Cleared 510(K)
- K845021MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA2Cleared 510(K)
- K812200INSUFFLATOR2Cleared 510(K)
- K781913INSUFFALATOR LAPARAOSCOPIC2Cleared 510(K)
- K772297INSUFFLATOR, MODEL G100 & 2002Cleared 510(K)
- HIGInsufflator, Hysteroscopic2Product Code
- HIHHysteroscope (And Accessories)2Product Code
- HIOSampler, Amniotic Fluid (Amniocentesis Tray)1Product Code
- LHZViscometer, Mucus, Cervical1Product Code
- MKOFalloposcope2Product Code
- MOKVaginoscope And Accessories2Product Code
- NKCTubing/Tubing With Filter, Insufflation, Laparoscopic1Product Code
- NMHLaparoscope And Accessories, Gynecologic, Reprocessed2Product Code
- NMILaparoscopic Insufflator And Accessories, Reprocessed1Product Code
- NVTTubing And Tubing/Filter Fits1Product Code
- NWVLaparoscopic Accessories, Gynecologic1Product Code
- NWWHysteroscope Accessories1Product Code
- PCFSampler, Endocervical2Product Code
- OHDGynecological Laparoscopic Kit2Product Code
- OHEForensic Evidence Sexual Assault Kit2Product Code
- OHFCuldocentesis Kit2Product Code
- OHMCesarean Section Tray2Product Code
- OKXTrocar Kit2Product Code
- PGTInsufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar2Product Code
- OKZEndometrial Sampling Kit2Product Code
- OSVInsufflator, Endoscopic Vessel Harvesting2Product Code
- PTZColposcope (And Colpomicroscope), Exempt2Product Code
- PVSFetal Blood Sampling Kit (Excludes Hiv Testing)2Product Code
- QHZSeal, Cervical, Mechanical, Unpowered1Product Code
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
INSUFLOW DEWHEART
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K091366
- 510(k) Type
- Traditional
- Applicant
- LEXION MEDICAL, LLC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/3/2009
- Days to Decision
- 118 days
- Submission Type
- Summary