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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

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
January 13, 2023
Date Received
April 6, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Potrero Medical, Inc.

  • K153655 — Accuryn Monitoring System (April 15, 2016)

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