OpenFlo Urinary Catheter— 510(k) K261141
Substantially EquivalentUrolution Medical, Inc.
FDA 510(k) clearance K261141 for OpenFlo Urinary Catheter, Substantially Equivalent on 2026-10-06. Applicant: Urolution Medical, Inc.. Device class: 2.
Summary
The OpenFlo Urinary Catheter is from Urolution Medical, filed under EZL, balloon retention-type catheters. The record doesn't describe what sets it apart from other catheters in the code.
Class II, 21 CFR 876.5130. The Gastroenterology and Urology panel reviewed it as a Traditional 510(k).
Urolution filed from Maple Grove, Minnesota. Review took 182 days (April 7 to October 6, 2026).
Clearance details
- Applicant
- Urolution Medical, Inc.
- Product code
- Product code EZL
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
Recent devices under product code EZL
view allAdverse events under product code EZL
product code EZL- Death
- 6
- Injury
- 796
- Malfunction
- 4,989
- Other
- 1
- Total
- 5,792
Source: openFDA MAUDE database, through . 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.