Product Code: EZP FDA class 2 21 CFR 876.4270

Rod, Colostomy

Gastroenterology, Urology

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.

510(k)s
2
FEI Numbers
17
Registration Numbers
17
Unique Applicants
2
Years Active
3

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K052229 COLOPLAST OSTOMY ROD, MODEL 12814
K040110 EASY LOOP, MODEL EZL-01

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.