DEN250043

Qoramatic Automated Stool Management

510(k) number
DEN250043
Device name
Qoramatic Automated Stool Management
Applicant
Cm Technologies, Inc. TX · US
Product code
SJB — Powered Fecal Management System
Decision date
2026-08-20
Date received
2025-09-15
Decision
Unknown
Clearance type
Direct
Advisory committee
Gastroenterology, Urology
Official FDA record: DEN250043
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.