Device Classification Name |
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
|
510(k) Number |
K160960 |
Device Name |
EsophyX® Z Device with SerosaFuse Fasteners and Accessories |
Applicant |
ENDOGASTRIC SOLUTIONS, INC. |
18109 NE 76TH STREET SUITE 100 |
REDMOND,
WA
98052
|
|
Applicant Contact |
STEVEN J HOFFMAN |
Correspondent |
ENDOGASTRIC SOLUTIONS, INC. |
18109 NE 76TH STREET SUITE 100 |
REDMOND,
WA
98052
|
|
Correspondent Contact |
STEVEN J HOFFMAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/05/2016 |
Decision Date | 05/01/2016 |
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
|
|
|