510(k) clearance

Qoramatic Automated Stool Management

FDA 510(k) source

510(k) number

DEN250043

Applicant

Cm Technologies, Inc.

Decision date

Aug 20, 2026

Date received

Sep 15, 2025

Decision

Unknown

Clearance type

Direct

Product code

SJB

Device type

Powered Fecal Management System

Device class

Class II

Regulation

21 CFR 876.5230

Advisory committee

Gastroenterology, Urology

Third party

N

Location

Carrollton, TX, US