510(k) K261141
K261141 is an FDA 510(k) premarket notification submitted by Urolution Medical, Inc. for the device "OpenFlo Urinary Catheter". The FDA issued a decision of Substantially Equivalent on Oct 6, 2026. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 6, 2026
- Date Received
- Apr 7, 2026
- 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
- 510(k)