Accuryn Monitoring System— 510(k) K153655

Name: FDA 510(k) clearance K153655
Creator: U.S. Food and Drug Administration
Published: 2016-04-15

Unknown

Potrero Medical, Inc.

FDA 510(k) clearance K153655 for Accuryn Monitoring System, Unknown on 2016-04-15. 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: 2015-12-21
Decision date: 2016-04-15
Decision: Unknown
Clearance type: Traditional
Location: San Francisco, 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.