510(k) K853514

RIGID ENDOSCOPE by American Edwards Laboratories — Product Code GCM

K853514 is an FDA 510(k) premarket notification submitted by American Edwards Laboratories for the device "RIGID ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on October 4, 1985. The device falls under product code GCM (Endoscope, Rigid), a Class II device regulated under 21 CFR 876.1500. American Edwards Laboratories has at least 10 other 510(k) clearances on record.