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 |
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 |
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 |
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 |
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 |
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 |
K040390 |
Stryker Endoscopy |
5900 OPTICAL CT.
| SAN JOSE |
CA |
95138 |
K201756 |
Stryker Sustainability Solutions |
1810 W Drake Drive
| Tempe |
AZ |
85283 |
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 |
|
|