Rod, Colostomy
The Colostomy Rod (product code EZP) is a support device placed beneath a newly formed colostomy loop to hold it in position against the abdominal wall during the initial healing period. It is an FDA Class 2 device (moderate risk), subject to general controls with no 510(k) required under the applicable submission type. It is regulated under 21 CFR 876.4270 in the Gastroenterology and Urology specialty. No special flags apply.
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Basic Information
- Product Code
- EZP
- Device Class
- FDA class 2
- Regulation Number
- 876.4270
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.