510(k) K170323

Entuit Start Initial Placement Gastrostomy Set by Cook Incorporated — Product Code KGC

K170323 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Entuit Start Initial Placement Gastrostomy Set". The FDA issued a decision of Substantially Equivalent on September 14, 2017. The device falls under product code KGC (Tube, Gastro-Enterostomy), a Class II device regulated under 21 CFR 876.5980. Cook Incorporated has at least 10 other 510(k) clearances on record.