510(k) clearance

Luja female

FDA 510(k) source

510(k) number

K263512

Applicant

Coloplast Corp.

Decision date

Oct 28, 2026

Date received

Sep 29, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

EZD

Device type

Catheter, Straight

Device class

Class II

Regulation

21 CFR 876.5130

Advisory committee

Gastroenterology, Urology

Statement or summary

Summary

Third party

N

Location

Minneapolis, MN, US