510(k) clearance

Irrigation/Urology Sets

FDA 510(k) source

510(k) number

K254111

Applicant

B.Braun Medical, Inc.

Decision date

Sep 10, 2026

Date received

Dec 19, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LJH

Device type

System, Irrigation, Urological

Device class

Class II

Regulation

21 CFR 876.5130

Advisory committee

Gastroenterology, Urology

Statement or summary

Summary

Third party

N

Location

Center Valley, PA, US