FDA 510(k) Applications for Medical Device:
Laparoscope, Gynecologic (And Accessories)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K190190 | 270Surgical Ltd |
4 Arie Regev Street | Natanya | 4250212 | |
| K210104 | 270Surgical Ltd. |
4 Arie Regev Street | Netanya | 4250212 | |
| K010510 | A & A MEDICAL, INC. |
9370 INDUSTRIAL TRACE | ALPHARETTA | GA | 30004-3383 |
| K955412 | AMERICAN SURGICAL DEVICES |
41917 OSGOOD RD. | FREMONT | CA | 94539 |
| K962777 | APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE | LAGUNA HILLS | CA | 92653 |
| K963359 | APPLIED MEDICAL RESOURCES |
26051 MERIT CIRCLE | LAGUNA HILLS | CA | 92653 |
| K062169 | APPLIED MEDICAL RESOURCES CORP. |
22872 Avenida Empresa | Rancho Santa Margarita | CA | 92688 |
| K040295 | APPLIED MEDICAL RESOURCES CORP. |
22872 Avenida Empresa | Rancho Santa Margarita | CA | 92688 |
| K972647 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K960262 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K021237 | COOPERSURGICAL, INC. |
KAISERSTR.9 | TUNINGEN | D-78609 | |
| K971837 | COOPERSURGICAL, INC. |
15 FOREST PKWY. | SHELTON | CT | 06484 |
| K971836 | COOPERSURGICAL, INC. |
15 FOREST PKWY. | SHELTON | CT | 06484 |
| K000199 | CORTEK ENDOSCOPY, INC. |
501 W. COLFAX, SUITE B | PALATINE | IL | 60067 |
| K980166 | CUDA PRODUCTS CO. |
6000 POWERS AVE. | JACKSONVILLE | FL | 32217 |
| K974763 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K990372 | DR. FRITZ GMBH |
13311 BROOKS DRIVE, SUITE E | BALDWIN PARK | CA | 91706 |
| K001220 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K965045 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K100280 | ETHICON, INC. |
ROUTE 22 WEST | SOMERVILLE | NJ | 08876-0151 |
| K993801 | ETHICON, INC. |
ROUTE 22 WEST | SOMERVILLE | NJ | 08876-0151 |
| K061050 | ETHICON, INC. |
P.O. BOX 151 | SOMERVILLE | NJ | 08876 |
| K131656 | ETHICON, INC. |
P.O. BOX 151 | SOMERVILLE | NJ | 08876-0151 |
| K954774 | GABRIS SURGICAL CORP. |
1432 NORTH GREAT NECK RD., | VIRGINIA BEACH | VA | 23454 |
| K003805 | GLOBAL ENDOSCOPY, INC. |
914 W. ESTES CT. | SCHAUMBURG | IL | 60193-4426 |
| K970968 | GUENTER BISSINGER MEDIZINTECHNIK GMBH |
GOTTLIEB-DAIMLER-STR. 5 | TENINGEN | D-79331 | |
| K020143 | GUIDANT CORPORATION, CARDIAC SURGERY |
3200 LAKESIDE DR. | SANTA CLARA | CA | 95054 |
| K033177 | GUNTER BISSINGER MEDIZINTECHNIK GMBH |
AMSTEL 320-I | AMSTERDAM | 1017 AP | |
| K963872 | GYNECARE INNOVATION CENTER |
1221 INNSBRUCK DR. | SUNNYVALE | CA | 94089 |
| K954775 | GYNECARE INNOVATION CENTER |
1221 INNSBRUCK DR. | SUNNYVALE | CA | 94089 |
| K962246 | HEALTH CARE INTERNATIONAL ASSOC. |
10551 WULFF DR. | VILLA PARK | CA | 92667 |
| K942389 | HOGAN & HARTSON |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004-1109 |
| K971255 | IMAGYN MEDICAL, INC. |
27651 LA PAZ RD. | LAGUNA NIGUEL | CA | 92656-3917 |
| K965055 | IMAGYN MEDICAL, INC. |
27651 LA PAZ RD. | LAGUNA NIGUEL | CA | 92656-3917 |
| K982428 | INNERVISION, INC. |
6258 SHADY GROVE RD. E. | MEMPHIS | TN | 38120 |
| K050404 | INTUITIVE SURGICAL, INC. |
950 KIFER RD. | SUNNYVALE | CA | 94086-5206 |
| K022384 | ISOLUX AMERICA |
1479 RAILHEAD BLVD. | NAPLES | FL | 34110-8444 |
| K972488 | KARL STORZ ENDOSCOPY |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K990004 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K962090 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K950335 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K951343 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K962985 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K981130 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K980694 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K964379 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K963949 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K963960 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K973304 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K150525 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
2151 E. GRAND AVE | EL SEGUNDO | CA | 90245 |
| K970712 | L & T S.N.C. DI E. LUCINI & C. |
20037 PADERNO DUGNANO | MILANO | ||
| K101458 | LINA MEDICAL APS |
1289 N. FORDHAM BLVD. | CHAPEL HILL | NC | 27517 |
| K971797 | LOUISVILLE LABORATORIES, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K963076 | LOUISVILLE LABORATORIES, INC. |
2400 CRITTENDEN DR. | LOUISVILLE | KY | 40217-1865 |
| K960810 | MARLO SURGICAL TECHNOLOGY |
1810 JOSEPH LLOYD PKWY. | WILLOUGHBY | OH | 44094 |
| K022748 | MEDICAL DEVICE SERVICES |
144 WEST BRIGHAM RD. | ST. GEORGE | UT | 84790 |
| K992480 | MEDIFIX, INC. |
8727 NARRAGANSETT | MORTON GROVE | IL | 60053-0000 |
| K172796 | MEDROBOTICS CORPORATION |
475 Paramount Drive | Raynham | MA | 02767 |
| K982276 | MICROPTIX INT'L, LLC. |
310 MAIN ST., SUITE LL-D | EAST HAVEN | CT | 06512 |
| K043013 | MILTEX, INC. |
589 DAVIES DRIVE | YORK | PA | 17402 |
| K971896 | NETOPTIX CORP. |
GALILEO PARK | STURBRIDGE | MA | 01566 |
| K080365 | NOUVAG AG |
REUSSWEHRSTRASSE 1 | GEBENSTORF | CH-5412 | |
| K961860 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K111788 | OLYMPUS AMERICA, INC. |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K955456 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K955403 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K201832 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K123365 | OLYMPUS MEDICAL SYSTEMS CORP. |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K111425 | OLYMPUS MEDICAL SYSTEMS CORP. |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K151011 | Olympus Medical Systems Corp. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K081173 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K080948 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K190744 | Olympus Winter & Ibe GmbH |
Kuehnstr. 61 | Hamburg | 22045 | |
| K965121 | ORIGIN MEDSYSTEMS, INC. |
135 CONSTITUTION DR. | MENLO PARK | CA | 94025 |
| K960936 | ORIGIN MEDSYSTEMS, INC. |
135 CONSTITUTION DR. | MENLO PARK | CA | 94025 |
| K062097 | PAJUNK GMBH MEDIZINTECHNOLOGIE |
KARL-HALL-STRASSE 1 | GEISINGEN, BADEN-WURTTEMBERG | 78187 | |
| K964450 | PILLING WECK GROUP |
TALL PINES PARK | JAFFREY | NH | 03452 |
| K221642 | Precision Robotics (Hong Kong) Limited |
Suite 611-612 Lakeside 2, 10W, | Hong Kong | 0000 | |
| K953360 | R-MED, INC. |
3465 NAVARRE AVE., BOX 167636 | OREGON | OH | 43616-7636 |
| K961922 | RANFAC CORP. |
30 DOHERTY AVE., P.O. BOX 635 | AVON | MA | 02322 |
| K003417 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K973737 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K960299 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K970105 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K003164 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K041321 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K201617 | Schoelly Fiberoptic GmbH |
Robert-Bosch-Strasse 1-3 | Denzlingen | 79211 | |
| K200216 | Scivita Medical Technology Co., Ltd. |
No.8, ZhongTian Xiang, Suzhou Industrial Park | Suzhou | 215000 | |
| K173111 | Sejong Medical Co., Ltd. |
11, Sinchon 2-ro | Paju-si | 10880 | |
| K200638 | Sejong Medical Co., Ltd. |
11, Sinchon 2-ro | Paju-si | 10880 | |
| K970151 | SMITH & NEPHEW, INC. |
130 FORBES BLVD. | MANSFIELD | MA | 02048 |
| K982149 | SMITH & NEPHEW, INC. |
160 DASCOMB RD. | ANDOVER | MA | 01810 |
| K960347 | SPIESS DESIGN, INC. |
290 TELSER RD. | LAKE ZURICH | IL | 60047 |
| K082451 | Stryker Endoscopy |
5900 OPTICAL CT. | SAN JOSE | CA | 95138 |
| K210116 | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. |
No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, | Cixi | 315300 | |
| K091010 | TROKAMED GMBH |
AMSTEL 320-I | AMSTERDAM | 1017AP | |
| K061268 | USGI MEDICAL |
1140 CALLE CORDILLERA | SAN CLEMENTE | CA | 92673 |
| K163320 | W.O.M. WORLD OF MEDICINE GMBH |
SALZUFER 8 | Berlin | 10587 | |
| K990732 | W.O.M. WORLD OF MEDICINE, GMBH |
194 BRANCH ST. | MANSFIELD | MA | 02048 |
| K964436 | WESTERN SURGICAL INSTRUMENT CO. |
11202 FOREST RAIN | SAN ANTONIO | TX | 78233 |
| K982518 | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH |
RUDOLF-DIESEL-RING 20 | SAUERLACH | D-82054 | |
| K992481 | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH |
RUDOLF-DIESEL-RING 20 | SAUERLACH | D-82054 | |
| K982515 | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH |
RUDOLF-DIESEL-RING 20 | SAUERLACH | D-82054 | |
| K960640 | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH |
8305 MELROSE DR. | LENEXA | KS | 66214 |
| K992513 | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH |
RUDOLF-DIESEL-RING 20 | SAUERLACH | D-82054 | |
| K993653 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
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