510(k) clearance
OpenFlo Urinary Catheter
- 510(k) number
- K261141
- Applicant
- Urolution Medical, Inc.
- Decision date
- Oct 6, 2026
- Date received
- Apr 7, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- EZL
- Device type
- Catheter, Retention Type, Balloon
- Device class
- Class II
- Regulation
- 21 CFR 876.5130
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Maple Grove, MN, US