510(k) K091832

ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER by Endogastric Solutions, Inc. — Product Code OCW

K091832 is an FDA 510(k) premarket notification submitted by Endogastric Solutions, Inc. for the device "ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER". The FDA issued a decision of Substantially Equivalent on July 22, 2009. The device falls under product code OCW (Endoscopic Tissue Approximation Device), a Class II device regulated under 21 CFR 876.1500. Endogastric Solutions, Inc. has at least 10 other 510(k) clearances on record.