Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F— 510(k) K221020

Name: FDA 510(k) clearance K221020
Creator: U.S. Food and Drug Administration
Published: 2023-01-13

Unknown

Potrero Medical, Inc.

FDA 510(k) clearance K221020 for Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F, Unknown on 2023-01-13. Applicant: Potrero Medical, Inc.. Device class: 2.

Clearance details

Applicant: Potrero Medical, Inc.
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2022-04-06
Decision date: 2023-01-13
Decision: Unknown
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.