Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter— 510(k) K173533

Name: FDA 510(k) clearance K173533
Creator: U.S. Food and Drug Administration
Published: 2018-03-29

Substantially Equivalent

Poiesis Medical, LLC

FDA 510(k) clearance K173533 for Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter, Substantially Equivalent on 2018-03-29. Applicant: Poiesis Medical, LLC. Device class: 2.

Clearance details

Applicant: Poiesis Medical, LLC
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2017-11-15
Decision date: 2018-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jupiter, FL, 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.