Class Class II

Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F (K221020)

K221020 2023-01-13 Traditional
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Description

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. — FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK221020
Clearance Date2023-01-13
Clearance TypeTraditional
Product CodeEZL
Regulation Number876.5130

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