510(k) K182832

Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set by Cook Incorporated — Product Code KGC

K182832 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set". The FDA issued a decision of Substantially Equivalent (kit) on June 26, 2019. 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.