Device Classification Name |
Colonoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K163492 |
Device Name |
Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear |
Applicant |
United states Endoscopy Group, Inc. |
5976 Heisley Road |
Mentor,
OH
44060
|
|
Applicant Contact |
Carroll Martin |
Correspondent |
United states Endoscopy Group, Inc. |
5976 Heisley Road |
Mentor,
OH
44060
|
|
Correspondent Contact |
Carroll Martin |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/13/2016 |
Decision Date | 01/06/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|