510(k) clearances

Qoramatic Automated Stool Management

Cm Technologies, Inc. · Gastroenterology, Urology

DEN250043UnknownDirectSJB
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Third party flag
N
City
Carrollton
Advisory committee description
Gastroenterology, Urology
Address 1
1321 Valwood Pkwy.
Address 2
Suite 530
Product code
SJB
Zip code
75006
Applicant
Cm Technologies, Inc.
Decision date
2026-08-20
Decision code
DENG
Country code
US
Device name
Qoramatic Automated Stool Management
Advisory committee
GU
Contact
Nishith Chasmawala
K number
DEN250043
State
TX
Date received
2025-09-15
Review advisory committee
GU
Postal code
75006
Decision description
Unknown
Clearance type
Direct
Harmonized identifiers (openFDA)
Device name
Powered Fecal Management System
Medical specialty description
Gastroenterology, Urology
Regulation number
876.5230
Device class
2
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.