Cement, Stomal Appliance, Ostomy
The Stomal Appliance Cement for Ostomy (product code EZR) is an adhesive substance used to secure ostomy appliances, such as pouches or flanges, to the peristomal skin. It is an FDA Class 1 device (lowest risk), subject only to general controls with no 510(k) required. It is regulated under 21 CFR 876.5900 in the Gastroenterology and Urology specialty. No special flags apply.
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Basic Information
- Product Code
- EZR
- Device Class
- FDA class 1
- Regulation Number
- 876.5900
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K844341 | UNITED SKIN BARRIER PASTE | Jan 18, 1985 | Substantially Equivalent | Howmedica Corp. |
| K803100 | STOMAHESIVE PASTE PROTECTIVE SKIN BARR | Jan 08, 1981 | Substantially Equivalent | E. R. Squibb & Sons, Inc. |
| K791146 | COLO-TAPE | Jul 30, 1979 | Substantially Equivalent | Suburban Ostomy Supply Co., Inc. |
| K761340 | OSTOMY KARAYA GUM POWDER | Mar 07, 1977 | Substantially Equivalent | Howmedica Corp. |
| K770230 | KARAYA GUM POWDER | Feb 28, 1977 | Substantially Equivalent | Atlantic Surgical |
| K761319 | KARAYA GUM PRODUCTS - PROCESS CHANGE | Feb 15, 1977 | Substantially Equivalent | Howmedica Corp. |
FEI Numbers
This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.