510(k) K221020

Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F by Potrero Medical, Inc. — Product Code EZL

K221020 is an FDA 510(k) premarket notification submitted by Potrero Medical, Inc. for the device "Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F". The FDA issued a decision of Substantially Equivalent (kit) on January 13, 2023. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Potrero Medical, Inc. has at least 1 other 510(k) clearance on record.