FDA 510(k) Applications for Medical Device:
Hysteroscope (And Accessories)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K022480 | ACMI CORPORATION |
136 TURNPIKE RD. | SOUTHBOROUGH | MA | 01772 |
| K180096 | AcuVu Inc. |
1749 Broadway Street | Redwood City | CA | 94063 |
| K211227 | AcuVu Inc. |
4546 El Camino Real #211 | Los Altos | CA | 94022 |
| K031974 | ASAP ENDOSCOPIC PRODUCTS GMBH |
KATHARINENSTR. 5 | LUEBECK | 23554 | |
| K160751 | BOSTON SCIENTIFIC |
100 BOSTON SCIENTIFIC WAY | MARLBOROUGH | MA | 01752 |
| K182975 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K191538 | Boston Scientific Corporation |
100 Boston Scientific Way | Marlborough | MA | 01752 |
| K192822 | Caldera Medical, Inc. |
5171 Clareton Drive | Agoura Hills | CA | 91301 |
| K233500 | Caldera Medical, Inc. |
4360 Park Terrace Drive | Westlake Village | CA | 91361 |
| K192811 | Caldera Medical, Inc. |
5171 Clareton Drive | Agoura Hills | CA | 91301 |
| K954164 | CONCEPTUS, INC. |
1021 HOWARD AVE. | SAN CARLOS | CA | 94070 |
| K972210 | CONCEPTUS, INC. |
1021 HOWARD AVE. | SAN CARLOS | CA | 94070 |
| K170660 | CooperSurgical, Inc. |
95 Corporate Drive | Trumbull | CT | 06611 |
| K183020 | CooperSurgical, Inc. |
95 Corporate Drive | Trumbull | CT | 06611 |
| K190639 | CooperSurgical, Inc. |
95 Corporate Drive | Trumbull | CT | 06611 |
| K200038 | CooperSurgical, Inc. |
95 Corporate Drive | Trumbull | CT | 06611 |
| K190113 | Corinth MedTech, Inc. |
1601 S. De Anza Blvd, Suite 200 | Cupertino | CA | 95014 |
| K191335 | Corinth MedTech, Inc. |
1601 S. De Anza Blvd, Suite 200 | Cupertino | CA | 95014 |
| K180752 | Corinth MedTech, Inc. |
1601 S. De Anza Blvd, Suite 221 | Cupertino | CA | 95014 |
| K180496 | Covidien |
60 Middletown Ave. | North Haven | CT | 06473 |
| K132384 | ENDOSEC CORPORATION |
4546 EL CAMINO REAL, STE 215 | LOS ALTOS | CA | 94022 |
| K123151 | ENDOSEE CORP |
4546 EL CAMINO REAL, | LOS ALTOS | CA | 94022 |
| K981800 | EQUAL DIAGNOSTICS, INC. |
115 SUMMIT DR. | EXTON | PA | 19341 |
| K994418 | ETHICON, INC. |
ROUTE 22 WEST | SOMERVILLE | NJ | 08876-0151 |
| K093218 | FEMSUITE, LLC |
19991 7TH STREET EAST | SONOMA | CA | 95476 |
| K962256 | GALILEO ELECTRO-OPTICS CORP. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K092421 | GIMMI GMBH |
ONE SCANLAN PLAZA | SAINT PAUL | MN | 55107 |
| K012869 | GIMMI GMBH |
AMSTEL 320-I | AMSTERDAM | 1017AP | |
| K003802 | GLOBAL ENDOSCOPY, INC. |
914 W. ESTES CT. | SCHAUMBURG | IL | 60193-4426 |
| K241987 | Guangzhou Red Pine Medical Instrument Co., Ltd. |
12 F, No.87 Luoxuan Avenue, | Guangzhou | 510000 | |
| K232003 | Guangzhou Red Pine Medical Instrument Co.,Ltd. |
12 F, No.87 Luoxuan Avenue, | Guangzhou | 510200 | |
| K971305 | GYNECARE INNOVATION CENTER |
1221 INNSBRUCK DR. | SUNNYVALE | CA | 94089 |
| K954648 | GYNECARE INNOVATION CENTER |
1221 INNSBRUCK DR. | SUNNYVALE | CA | 94089 |
| K040302 | GYNECARE, A DIV. OF ETHICON, INC. |
U.S. ROUTE 22 WEST | SOMERVILLE | NJ | 08876 |
| K992901 | GYNECARE, INC. |
P.O. BOX 151 | SOMMERVILLE | NJ | 08876-0151 |
| K962482 | GYNECARE, INC. |
235 CONSTITUTION DR. | MENIO PARK | CA | 94025 |
| K982738 | GYNECARE, INC. |
235 CONSTITUTION DR. | MENIO PARK | CA | 94025 |
| K092278 | GYRUS ACMI, INC. |
136 TURNPIKE RD. | SOUTHBOROUGH | MA | 01772 |
| K982771 | GYRUS MEDICAL LTD. |
FORTRAN RD., ST. MELLONS | CARDIFF | CF3 0LT | |
| K993749 | GYRUS MEDICAL LTD. |
FORTRAN RD., ST. MELLONS | CARDIFF | CF3 0LT | |
| K991563 | HENKE SASS WOLF OF AMERICA, INC. |
73 EAGLES NEST RD. | DUXBURY | MA | 02332 |
| K952186 | HENKE-SASS WOLF, GMBH. |
POSTFACH 2459 | TUTTLINGEN | 78507 | |
| K173070 | Henke-Sass, Wolf GmbH |
Keltenstrasse 1 | Tuttlingen | 78532 | |
| K152723 | HOLOGIC, INC |
250 CAMPUS DRIVE | MARLBOROUGH | MA | 01752 |
| K181974 | Hologic, Inc |
250 Campus Drive | Marlborough | MA | 01752 |
| K182006 | Hologic, Inc |
250 Campus Drive | Marlborough | MA | 01752 |
| K120593 | HOLOGIC, INC. |
250 CAMPUS DRIVE | MARLBOROUGH | MA | 01752 |
| K142029 | HOLOGIC, INC. |
250 CAMPUS DRIVE | MARLBOROUGH | MA | 01752 |
| K172566 | Hologic, Inc. |
250 Campus Drive | Marlborough | MA | 01752 |
| K121868 | HOLOGIC, INC. |
250 CAMPUS DRIVE | MARLBOROUGH | MA | 01752 |
| K173901 | Hologic, Inc. |
250 Campus Drive | Marlbrough | MA | 01752 |
| K131581 | HOLOGIC, INC. |
250 CAMPUS DRIVE | MARLBOROUGH | MA | 01752 |
| K131736 | HOLOGIC, INC. |
250 CAMPUS DRIVE | MARLBOROUGH | MA | 01752 |
| K122563 | HOLOGIC, INC. |
250 CAMPUS DRIVE | MARLBOROUGH | MA | 01752 |
| K122498 | HOLOGIC, INC. |
250 CAMPUS DRIVE | MARLBOROUGH | MA | 01752 |
| K191281 | Hologic, Inc. |
250 Campus Drive | Marlborough | MA | 01752 |
| K202445 | Hysterovue, Inc. |
5337 14th Place SE | Bellevue | WA | 98006 |
| K972426 | IMAGYN MEDICAL, INC. |
27651 LA PAZ RD. | LAGUNA NIGUEL | CA | 92656-3917 |
| K961688 | IMAGYN MEDICAL, INC. |
27651 LA PAZ RD. | LAGUNA NIGUEL | CA | 92656-3917 |
| K961506 | IMAGYN MEDICAL, INC. |
27651 LA PAZ RD. | LAGUNA NIGUEL | CA | 92656-3917 |
| K100559 | INTERLACE MEDICAL INC. |
135 NEWBURY ST | FRAMINGHAM | MA | 01701 |
| K073690 | INTERLACE MEDICAL, INC. |
139 NEWBURY STREET | FRAMINGHAM | MA | 01701 |
| K081070 | INTERLACE MEDICAL, INC. |
139 NEWBURY STREET | FRAMINGHAM | MA | 01701 |
| K091100 | INTERLACE MEDICAL, INC. |
555 THIRTEEN STREET, N.W. | WASHINGTON | DC | 20010 |
| K091465 | INTERLACE MEDICAL, INC. |
135 NEWBURY STREET | FRAMINGHAM | MA | 01701 |
| K102686 | INTERLACE MEDICAL, INC. |
139 NEWBURY STREET | FRAMINGHAM | MA | 01701 |
| K123330 | IOGYN, INC. |
5353 WAYZATA BOULEVARD | MINNEAPOLIS | MN | 55416 |
| K210270 | Jiangsu Jiyuan Medical Technology Co., Ltd. |
No.48 CECEP (Taizhou) Environmental Protection Technology | Jiangsu | 225300 | |
| K992027 | KARL STORZ ENDOSCOPY |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K990411 | KARL STORZ ENDOSCOPY |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K223885 | Karl Storz Endoscopy America, Inc. |
2151 E. Grand Ave | El Segundo | CA | 90245 |
| K961605 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K983901 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K001740 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K983569 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K971518 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K223520 | Karl Storz-Endoscopy-America, Inc. |
2151 E. Grand Avenue | El Segundo | CA | 90245 |
| K193007 | LiNA Medical ApS |
Formervangen 5 | Glostrup | 2600 | |
| K171113 | LiNA Medical ApS |
Formervangen 5 | Glostrup | 2600 | |
| K240978 | MacroLux Medical Technology Co., Ltd. |
301, Building 3, NamTai Inno Park In Guang Ming Avenue | Shenzhen | ||
| K192100 | Meditrina, Inc. |
1190 Saratoga Avenue, Suite 180 | San Jose | CA | 95129 |
| K191958 | Meditrina, Inc. |
1190 Saratoga Avenue, Suite 180 | San Jose | CA | 95129 |
| K190372 | Meditrina, Inc. |
1601 S. De Anza Blvd, Suite 165 | Cupertino | CA | 95014 |
| K223813 | Meditrina, Inc. |
1190 Saratoga Avenue, Suite 180 | San Jose | CA | 95129 |
| K213171 | Meditrina, Inc. |
1190 Saratoga Avenue, Suite 180 | San Jose | CA | 95129 |
| K982659 | MEDIVISION SCOPE SERVICE CENTER, INC. |
1440 SOUTH STATE COLLEGE BLVD. | ANAHEIM | CA | 92806 |
| K990910 | MTP MEDICAL TECHNICAL PROMOTION GMBH |
P.O. BOX 1954 | CULVER CITY | CA | 90232 |
| K141515 | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
22134 SHERMAN WAY | CANOGA PARK | CA | 91303 |
| K974297 | NETOPTIX CORP. |
49 PLAIN ST. | NORTH ATTLEBORO, | MA | 02760 |
| K981828 | NETOPTIX CORP. |
49 PLAIN ST. | NORTH ATTLEBORO, | MA | 02760 |
| K962271 | NORTHGATE TECHNOLOGIES, INC. |
600 CHURCH RD. | ELGIN | IL | 60123 |
| K151275 | nVision Medical |
250 King Street, #676 | San Francisco | CA | 94107 |
| K160510 | nVision Medical Corporation |
2500 Grant Road, G01 | Mountain View | CA | 94040 |
| K091838 | OBP MEDICAL |
360 MERRIMACK STREET, | LAWERENCE | MA | 01843 |
| K954488 | OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K221557 | Olympus Medical Systems Corporation |
2951 Ishikawa-cho, Hachioji-shi | Tokyo | ||
| K022445 | OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K213207 | Olympus Winter & Ibe GmbH |
Kuehnstr. 61 | Hamburg | 22045 | |
| K053583 | OPTIVIA MEDICAL LLC |
101 N. CHESTNUT STREET | WINSTON-SALEM | NC | 27101 |
| K240401 | OriGyn Medical Technology (Hangzhou) Co., Ltd. |
Rm 310,3F,Bldg 6,No.688,Bin'an Rd, Changhe Str, | Hangzhou | ||
| K182675 | Polygon Medical, Inc. |
18 Hillside Drive | Holliston | MA | 01746 |
| K190797 | Reed Medical (Zhejiang) Co., Ltd. |
8th Floor, 10th Building, No. 988 of Xinxing Two Road | Pinghu | 314200 | |
| K000673 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K971420 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K033113 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K980302 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
353 CORPORATE WOODS PKWY. | VERNON HILLS | IL | 60061 |
| K243382 | RZ Medizintechnik GmbH |
Unter Ha▀len 20/22 | Tuttlingen | 78532 | |
| K150158 | Schoelly Fiberoptic GmbH |
Robert-Bosch-Str. 1-3 | Denzlingen | 79211 | |
| K201970 | Schoelly Fiberoptic GmbH |
Robert-Bosch-Str. 1-3 | Denzlingen | D-79211 | |
| K181545 | Shanghai AnQing Medical Instrument CO., Ltd. |
150 Cailun Road, Zhangjiang High-Tech Park | Shanghai | 201210 | |
| K041774 | SMITH & NEPHEW, INC. |
150 Minuteman Road | Andover | MA | 01810 |
| K971188 | SMITH & NEPHEW, INC. |
160 DASCOMB RD. | ANDOVER | MA | 01810 |
| K031787 | SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K013870 | SMITH & NEPHEW, INC. |
160 DASCOMB RD. | ANDOVER | MA | 01810 |
| K161763 | Smith & Nephew, Inc. |
150 Minuteman Rd. | Andover | MA | 01810 |
| K103389 | SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K132015 | SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K110038 | SMITH & NEPHEW, INC. |
150 Minuteman Road | Andover | MA | 01810 |
| K112134 | SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K152143 | SMITH & NEPHEW, INC. |
150 Minuteman Road | Andover | MA | 01810 |
| K233635 | Stryker Endoscopy |
5900 Optical Court | San Jose | CA | 95138 |
| K252012 | Stryker Endoscopy |
5900 Optical Court | San Jose | CA | 95138 |
| K040390 | Stryker Endoscopy |
5900 OPTICAL CT. | SAN JOSE | CA | 95138 |
| K201756 | Stryker Sustainability Solutions |
1810 W Drake Drive | Tempe | AZ | 85283 |
| K231260 | Suzhou AcuVu Medical Technology Co., Ltd. |
B1-212, Bio-Nano Park, 218 Xinghu Street, | Suzhou | 215125 | |
| K955119 | SYMBIOSIS CORP. |
8600 N.W. 41 ST. | MIAMI | FL | 33166 |
| K190827 | UVision360 Inc. |
158 Wind Chime Ct. Ste. 201 | Raleigh | NC | 27615 |
| K192278 | UVision360 Inc. |
158 Wind Chime Ct. Ste. 201 | Raleigh | NC | 27615 |
| K071127 | VISION-SCIENCES, INC. |
5 WHITCOMB AVE. | AYER | MA | 01432 |
| K971374 | WILSON GREATBATCH TECHNOLOGIES, INC. |
4100 BARTON RD. | CLARENCE | NY | 14031 |
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