|
Device |
bronchoscope (flexible or rigid) |
Definition |
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. 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 | EOQ |
Regulation Number |
874.4680
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AMBU A/S |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
ANREI MEDICAL (HANGZHOU) CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AURIS HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AURIS SURGICAL ROBOTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AXESS VISION TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BODY VISION MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BRONCUS MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIFILM CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
FUJIFILM CORPORATON |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INTUITIVE SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTUITIVE SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
KARL STORZ ENDOSCOPY AMERICA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO-TECH (NANJING) CO., LTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOAH MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS MEDICAL SYSTEMS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
OLYMPUS MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OTU MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PENTAX OF AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SCIVITA MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SERPEX MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VERAN MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VERATHON MEDICAL (CANADA) ULC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
WILSON-COOK MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|