ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER

Endoscopic Tissue Approximation Device

ENDOGASTRIC SOLUTIONS, INC.

The following data is part of a premarket notification filed by Endogastric Solutions, Inc. with the FDA for Endogastric Solutions Stomaphyx System With Serosafuse Fastener.

Pre-market Notification Details

Device IDK091832
510k NumberK091832
Device Name:ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER
ClassificationEndoscopic Tissue Approximation Device
Applicant ENDOGASTRIC SOLUTIONS, INC. 8210 154TH AVE. NE Redmond,  WA  98052
ContactSteve Hoffman
CorrespondentSteve Hoffman
ENDOGASTRIC SOLUTIONS, INC. 8210 154TH AVE. NE Redmond,  WA  98052
Product CodeOCW  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-22
Decision Date2009-07-22
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.