510(k) K213356

Entuit PEG, Entuit PEGJ by Wilson-Cook Medical, Inc. — Product Code PIF

K213356 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Entuit PEG, Entuit PEGJ". The FDA issued a decision of Substantially Equivalent (with conditions) on January 20, 2022. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.