510(k) K113310

ENDOGATER AVANTAGE CO2 INSUFFLATOR by Byrne Medical, Inc. — Product Code FCX

K113310 is an FDA 510(k) premarket notification submitted by Byrne Medical, Inc. for the device "ENDOGATER AVANTAGE CO2 INSUFFLATOR". The FDA issued a decision of Substantially Equivalent on June 20, 2012. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500. Byrne Medical, Inc. has at least 10 other 510(k) clearances on record.