Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K143088 |
Device Name |
GastriSail Gastric Positioning System |
Applicant |
COVIDIEN |
60 MIDDLETOWN AVE. |
NORTH HAVEN,
CT
06473
|
|
Applicant Contact |
Debbie Peacock |
Correspondent |
COVIDIEN |
60 MIDDLETOWN AVE. |
NORTH HAVEN,
CT
06473
|
|
Correspondent Contact |
Debbie Peacock |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 10/28/2014 |
Decision Date | 02/25/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|