|
Device |
hysteroscope (and accessories) |
Product Code | HIH |
Regulation Number |
884.1690
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACUVU INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BOSTON SCIENTIFIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CALDERA MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
COOPERSURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CORINTH MEDTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
COVIDIEN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDOSEC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDOSEE CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FEMSUITE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GIMMI GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GYRUS ACMI, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HENKE-SASS, WOLF GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOLOGIC, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HOLOGIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
HYSTEROVUE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTERLACE MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTERLACE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
IOGYN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU JIYUAN MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KARL STORZ ENDOSCOPY AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KARL STORZ-ENDOSCOPY-AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LINA MEDICAL APS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MACROLUX MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDITRINA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NVISION MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NVISION MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OBP MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS WINTER & IBE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORIGYN MEDICAL TECHNOLOGY (HANGZHOU) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POLYGON MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REED MEDICAL (ZHEJIANG) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCHOELLY FIBEROPTIC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
STRYKER ENDOSCOPY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER SUSTAINABILITY SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU ACUVU MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UVISION360 INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
|
|
|