FDA 510(k) Applications for Medical Device:
Insufflator, Laparoscopic

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K000027 A & A MEDICAL, INC. 9370 INDUSTRIAL TRACE
ALPHARETTA GA 30004-3383
K930767 ACORN MEDICAL, INC. 334 EAST CENTER ST.
NAZARETH PA 18064
K934928 ANDRONIC DEVICES, LTD. SUITE 140
RICHMOND, B.C. CANADA V6V 2J2
K934926 ANDRONIC DEVICES, LTD. SUITE 140
RICHMOND, B.C. CANADA V6V 2J2
K924481 APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE
LAGUNA HILLS CA 92653
K070651 ARAGON SURGICAL INC. 1810 EMBARCADERO ROAD, SUITE B
PALO ALTO CA 94303
K073452 ARAGON SURGICAL INC. 1810 EMBARCADERO ROAD, SUITE B
PALO ALTO CA 94303
K922777 ARBOR TECHNOLOGIES, INC. 3728 PLAZA DR.
ANN ARBOR MI 48108
K922245 ARMM, INC. 17744 SAMPSON LN.
HUNTINGTON BEACH CA 92647
K941685 BLUE PLANET INDUSTRIES, INC. 14224 43RD. AVENUE NORTH
PLYMOUTH MN 55446
K913242 BRYAN CORP. FOUR PLYMPTON ST.
WOBURN MA 01801
K171139 Buffalo Filter, LLC 5900 Genesee Street
Lancaster NY 14086
K934115 CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST
LANGHORNE PA 19047
K913873 CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST
LANGHORNE PA 19047
K112975 CARDIA INNOVATION AB 7307 GLOCHESTER DRIVE
EDINA MN 55435
K052125 CARDIA INNOVATION AB 7307 GLOCHESTER DRIVE
EDINA MN 55435
K935639 CHARLES POLO & CO., INC. 12714 HOOVER ST.
GARDEN GROVE CA 92841
K905705 CIRCON ACMI 300 STILLWATER AVE.
STAMFORD CT 06904 1971
K914101 CIRCON VIDEO 300 STILLWATER AVE.
STANFORD CT 06904 1971
K943954 CONMED CORP. 3040 EAST RIVER RD.
DAYTON OH 45439
K172516 ConMed Corporation 488 Wheelers Farms Road
Milford CT 06461
K935503 DAVOL, INC. 100 SOCKANOSSETT CROSSROAD
CRANSTON RI 02920
K962683 DEKNATEL, INC. 49 PLAIN ST.
NORTH ATTLEBORO MA 02760
K945789 DEROYAL INDUSTRIES, INC. 200 DEBUSK LN.
POWELL TN 37849
K934131 DEROYAL INDUSTRIES, INC. 200 DEBUSK LN.
POWELL TN 37849
K944509 DEXIDE, INC. 7509 FLAGSTONE DR.
FORT WORTH TX 76118
K905549 DEXIDE, INC. P.O. BOX 185789
FT. WORTH TX 76181
K905417 ELMED, INC. 60 WEST FAY AVE.
ADDISON IL 60101
K950219 ENDOLAP, INC. 3012 MERCY DR.
ORLANDO FL 32808
K983925 ETHICON ENDO-SURGERY, INC. 4545 CREEK RD.
CINCINNATI OH 45242-2839
K910883 F.M. WIEST USA, INC. P.O. BOX 637
ORADEL NJ 07649
K162582 FISHER & PAYKEL HEALTHCARE 15 MAURICE PAYKEL PLACE, EAST TAMAKI
AUCKLAND 2013
K993625 GENICON, LC 573 WATERSCAPE WAY
ORLANDO FL 32828
K920205 GEORGIA BIOMEDICAL RESEARCH GROUP, INC. 250 CHARTER LANE, STE. 101
MACON GA 31210
K970866 GEORGIA BIOMEDICAL, INC. 49 PLAIN ST.
NORTH ATTLEBORO MA 02760
K172835 GRI Medical and Electronic Technology Co., Ltd. 105 Honggao Road, Xiuzhou Industry Zone
Jiaxing 314031
K900878 GYNESCOPE CORP. 1810 JOSEPH LLOYD PKWY.
WILLOUGHBY OH 44094
K142700 GYNETECH PTY. LTD. Unit 7, 6-8 Macquarie Drive
Thomastown 3095
K930013 HI TEC MEDICAL VERTRIEBS-GMBH FUR INNOVATIVE MEDIZ WILHELMSTR. 5
TUTTLINGEN
K955477 HI TEC MEDICAL VERTRIEBS-GMBH FUR INNOVATIVE MEDIZ JUNKERSTRASSE-1
TUTTLINGEN D-78532
K090652 HIPPOKRATEC GMBH AM WINDFELD 36
MIEBACH, BAVARIA 83714
K933094 INMAN MEDICAL CORP. 6316 AIRPORT FREEWAY
FORT WORTH TX 76117
K963423 KARL STORZ ENDOSCOPY 600 CORPORATE POINTE
CULVER CITY CA 90230-7600
K951694 KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE
CULVER CITY CA 90230 7600
K161554 KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVENUE
EL SEGUNDO CA 90245
K934043 KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD.
CULVER CITY CA 90232 3578
K934114 KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD.
CULVER CITY CA 90232 3578
K962863 KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE
CULVER CITY CA 90230-7600
K080852 KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE
CULVER CITY CA 90230-7600
K951961 KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE
CULVER CITY CA 90230 7600
K980134 KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE
CULVER CITY CA 90230-7600
K955073 KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE
CULVER CITY CA 90230-7600
K921837 KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD
TIMONIUM MD 21093
K781913 KLI
K772297 KLI
K914201 LEISEGANG MEDICAL, INC. 6401 CONGRESS AVE.
BOCA RATON FL 33487 2883
K170799 LEXION Medical LLC 545 Atwater Circle
St Paul MN 55103
K090456 LEXION MEDICAL, LLC. 5000 TOWNSHIP PKWY
ST. PAUL MN 55110
K063546 LEXION MEDICAL, LLC. 5000 TOWNSHIP PKWY
ST. PAUL MN 55110
K091366 LEXION MEDICAL, LLC. 5000 TOWNSHIP PKWY
ST. PAUL MN 55110
K120640 LEXION MEDICAL, LLC. 5000 TOWNSHIP PKWY
ST. PAUL MN 55110
K140263 LEXION MEDICAL, LLC. 4486 TIMBERLINE CT
VADNAIS HEIGHTS MN 55127
K132204 LEXION MEDICAL, LLC. 4486 TIMBERLINE CT
VADNAIS HEIGHTS MN 55127
K132203 LEXION MEDICAL, LLC. 4486 TIMBERLINE CT
VADNAIS HEIGHTS MN 55127
K101320 LEXION MEDICAL, LLC. 5000 TOWNSHIP PKWY
ST. PAUL MN 55110
K102136 LEXION MEDICAL, LLC. 5000 TOWNSHIP PKWY
ST. PAUL MN 55110
K112357 LEXION MEDICAL, LLC. 545 ATWATER CIRCLE
ST PAUL MN 55103
K910983 M.D. ENGINEERING, INC. 2536 BARRINGTON COURT
HAYWARD CA 94545
K914153 MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY.
WILLOUGHBY OH 44094
K925691 MECTRA LABS, INC. HIGHWAY 231 SOUTH,
BLOOMFIELD IN 47424
K920959 MECTRA LABS, INC. HIGHWAY 231 SOUTH,
BLOOMFIELD IN 47424
K021247 MECTRA LABS, INC. P.O. BOX 350
BLOOMFIELD IN 47424
K915694 MEDICAL DEVICES, INC. 83 HOBART ST.
HACKENSACK NJ 07601
K871928 MEDLINE INDUSTRIES, INC. 99 INVERNESS DRIVE EAST
ENGLEWOOD CO 80112
K845021 MEDLINE INDUSTRIES, INC. 99 INVERNESS DRIVE EAST
ENGLEWOOD CO 80112
K111955 MEDLINE, INDUSTRIES, INC. ONE MEDLINE PLACE
MUNDELEIN IL 60060
K925558 MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE
HERNDON VA 20170 4822
K936155 MICRO MEDICAL DEVICES, INC. 317 PARAGON WAY
CASTLE PINES VILLAGE CO 80104
K912044 MULTIGON INDUSTRIES, INC. P.O. BOX 2485
MT. VERNON NY 10551
K001068 NBS PRODUCTS CO 257 LIVINGSTON AVE.
NEW BRUNSWICK NJ 08901
K120151 NORTHGATE TECHNOLOGIES INC. 1591 SCOTTSDALE COURT
ELGIN IL 60123
K022052 NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD.
ELGIN IL 60123
K992381 NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD.
ELGIN IL 60123
K972675 NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD.
ELGIN IL 60123
K041560 NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD.
ELGIN IL 60123
K914403 NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR.
ARLINGTON HEIGHTS IL 60004
K010053 NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD.
ELGIN IL 60123
K033614 NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD.
ELGIN IL 60123
K915051 NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR.
ARLINGTON HEIGHTS IL 60004
K905481 NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR.
ARLINGTON HEIGHTS IL 60004
K935862 NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR.
ARLINGTON HEIGHTS IL 60004
K973447 NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD.
ELGIN IL 60123
K983326 NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD.
ELGIN IL 60123
K914402 NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR.
ARLINGTON HEIGHTS IL 60004
K914401 NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR.
ARLINGTON HEIGHTS IL 60004
K911179 NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR.
ARLINGTON HEIGHTS IL 60004
K922244 O.R. CONCEPTS, INC. 200 N. OAK ST.
ROANOKE TX 76262
K930696 O.R. RESOURCES, INC. P.O. BOX 6563
ANNAPOLIS MD 21401
K953162 OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR.
MELVILLE NY 11747 3157
K122180 OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY
CENTER VALLEY PA 18034-0610
K110294 OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY
CENTER VALLEY PA 18034-0610
K014166 OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR.
MELVILLE NY 11747-3157
K030469 PALL MEDICAL 555 THIRTEENTH STREET, N.W.
WASHINGTON DC 20004
K033991 PALL MEDICAL 555 THIRTEENTH STREET, N.W.
WASHINGTON DC 20004
K923194 PROCEDURE PRODUCTS, INC. 1801 WEST 4TH PLAIN BLVD.
VANCOUVER WA 98660
K812200 REZNIK INSTRUMENTS
K072753 RG MEDICAL USA 468 CRAIGHEAD ST.
NASHVILLE TN 37204
K921756 RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY.
VERNON HILLS IL 60061
K882185 RICHARD WOLF MEDICAL INSTRUMENTS CORP. 7046 LYNDON AVE.
ROSEMONT IL 60018
K981334 RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY.
VERNON HILLS IL 60061
K991906 RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY.
VERNON HILLS IL 60061
K934884 RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY.
VERNON HILLS IL 60061
K002328 RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY.
VERNON HILLS IL 60061
K000180 RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY.
VERNON HILLS IL 60061
K942207 RICHARD-ALLAN MEDICAL 8850 M89, BOX 351
RICHLAND MI 49083 0351
K913979 SNOWDEN-PENCER 2058 KILMAN DR.
TUCKER GA 30084
K920986 SNOWDEN-PENCER 2058 KILMAN DR.
TUCKER GA 30084
K913835 SNOWDEN-PENCER 2058 KILMAN DR.
TUCKER GA 30084
K070783 SOPRO 124 GAITHER DRIVE
MT. LAUREL NJ 08054
K153367 SOPRO - ACTEON GROUP ZAC ATHELIA IV AVENUE DES GENEVRIERS
LA CIOTAT 13705
K920114 SPIESS DESIGN, INC. 495 LINDBERG LN.
NORTHBROOK IL 60062
K003792 STRYKER CORP. 2590 WALSH AVE.
SANTA CLARA CA 95051
K921963 SUN MEDICAL, INC. 1170 CORPORATE DRIVE WEST
ARLINGTON TX 76006
K922038 SURGEON SURGICAL INSTRUMENTATION, INC. 1030 RICHFIELD RD.
PLACENTIA CA 92670
K955393 SURGICAL INNOVATIONS PLC 1070 THORNWOOD LN.
DACULA GA 30211-3007
K121336 SURGIQUEST, INC. 333 Quarry Rd
Milford CT 06460
K103692 SURGIQUEST, INC. 12 CASCADE BLVD.
ORANGE CT 06477
K143404 SURGIQUEST, INC. 333 Quarry Rd
Milford CT 06460
K003703 TAUT, INC. 2571 KANEVILLE COURT
GENEVA IL 60134
K173545 TEMED Unit 3, Keynor Farm
Sidlesham PO20 7LL
K162648 TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. A02, PLANT B, NO. 278, HANGKONG RD, TIANJIN FREE TRADE ZONE
TIANJIN 300308
K900808 TREK MEDICAL PRODUCTS, INC. 820 SWAN DR.
MUKWONAGO WI 53149
K111441 UNIMAX MEDICAL SYSTEMS, INC. NO. 45, MINSHEN RD.
TAIPEI COUNTY 251
K150068 Unimicro Medical Systems (ShenZhen) Co.,Ltd. 2/F, Bldg 31, The 3rd Industrial Area, Mashantou,
Shenzhen 518106
K911479 UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD.
MENTOR OH 44060
K061387 VERESURE, INC. 25 HARTFORD AVE.
SAN CARLOS CA 94070
K930192 VITAL CONCEPTS, INC. 4315 AIRWEST DR. S.E.
GRAND RAPIDS MI 49512
K022318 VOMED VOLZER MEDIZINTECHNIK GMBH & CO. AMSTEL 320-I
AMSTERDAM 1017AP
K153513 W.O.M WORLD OF MEDICINE GMBH SALZUFER 8
BERLIN 10587
K170784 W.O.M World Of Medicine GmbH Salzufer 8
Berlin 10587
K950035 W.O.M. GMBH PASCALSTRABE 11
BERLIN D-10587
K001533 W.O.M. GMHB 194 BRANCH ST.
MANSFIELD MA 02048
K030837 W.O.M. WORLD OF MEDICINE AG 368 NORTH ASAPH STREET
ALEXANDRIA VA 22314
K060723 W.O.M. WORLD OF MEDICINE AG 1490 CAMBRIDGE STREET
CAMBRIDGE MA 02139
K063367 W.O.M. WORLD OF MEDICINE AG 1480 CAMBRIDGE STREET
CAMBRIDGE MA 02139
K921264 W.O.M. WORLD OF MEDICINE, GMBH 8536 CALLE TIOGA
TUCSON AR 85704
K981859 W.O.M. WORLD OF MEDICINE, GMBH 1775 I STREET, N.W.
WASHINGTON DC 20006-2401
K955791 W.O.M. WORLD OF MEDICINE, GMBH 1300 I STREET, N.W.
WASHIGNTON DC 20005-3306
K973432 W.O.M. WORLD OF MEDICINE, GMBH PASCALSTRABE 11
BERLIN D-10587
K990662 WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH RUDOLF-DIESEL-RING 20
SAUERLACH D-82054
K031014 WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH RUDOLF-DIESEL-RING 20
SAUERLACH D-82054
K011510 WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH RUDOLF-DIESEL-RING 20
SAUERLACH D-82054
K941438 WISAP/U.S.A. W-8029 SAUERLACH B.
MUNCHEN,




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