|
Device |
bronchoscope accessory |
Definition |
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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 | KTI |
Regulation Number |
874.4680
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACCLARENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BRYAN MEDICAL , INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DISA MEDINOTEC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN TT MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GA HEALTH COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTUIT MEDICAL PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
M/S MERIL LIFE SCIENCES PVT. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIVATORS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICRO-TECH (NANJING) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS MEDICAL SYSTEMS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PRAXIS MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SERPEX MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPIRATION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|