Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K142113
Device Classification Name
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
More FDA Info for this Device
510(K) Number
K142113
Device Name
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Applicant
ENDOGASTRIC SOLUTIONS, INC.
340 JONES LANE
GARDNERVILLE, NV 89640 US
Other 510(k) Applications for this Company
Contact
MICHAEL A DANIEL
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
ODE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/04/2014
Decision Date
09/30/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact