Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K160654 |
Device Name |
GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) |
Applicant |
Covidien LLC |
60 MIDDLETOWN AVE |
North Haven,
CT
06473
|
|
Applicant Contact |
Rebecca Magnanimo |
Correspondent |
Covidien LLC |
60 MIDDLETOWN AVE |
North Haven,
CT
06473
|
|
Correspondent Contact |
Rebecca Magnanimo |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 03/08/2016 |
Decision Date | 05/04/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|