510(k) K913294

SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT by Surgitek Medical Engineering Corp. — Product Code GCA

K913294 is an FDA 510(k) premarket notification submitted by Surgitek Medical Engineering Corp. for the device "SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT". The FDA issued a decision of Substantially Equivalent on October 4, 1991. The device falls under product code GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection), a Class II device regulated under 21 CFR 876.5010. Surgitek Medical Engineering Corp. has at least 10 other 510(k) clearances on record.