510(k) K193612

AMT Suture Delivery System by Applied Medical Technology, Inc. — Product Code KGC

K193612 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "AMT Suture Delivery System". The FDA issued a decision of Substantially Equivalent on March 12, 2020. The device falls under product code KGC (Tube, Gastro-Enterostomy), a Class II device regulated under 21 CFR 876.5980. Applied Medical Technology, Inc. has at least 10 other 510(k) clearances on record.