|
Device |
gastroscope and accessories, flexible/rigid |
Definition |
To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). |
Product Code | FDS |
Regulation Number |
876.1500
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AMBU A/S |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EASYGLIDE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ENDOCHOICE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDOCHOICE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EVOENDO INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIFILM CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
FUJIFILM CORPORATON |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIFILM HEALTHCARE AMERICAS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJINON INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJINON, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GI SCIENTIFIC LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUIZHOU XZING TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IQ ENDOSCOPES LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEPTUNE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PENTAX MEDICAL COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PENTAX MEDICAL OF AMERICA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PENTAX OF AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SUMITOMO BAKELITE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED STATES ENDOSCOPY GROUP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VISURA TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|