FDA product code EZR: Cement, Stomal Appliance, Ostomy
EZR is the FDA product code for cement, stomal appliance, ostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 6 510(k) submissions under EZR, from 4 different applicants. The average 510(k) review took 47 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Cement, Stomal Appliance, Ostomy |
| Device class | Class I |
| Regulation | 21 CFR 876.5900 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EZR clearance
Top EZR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Howmedica Corp. | 3 | 1985-01-18 |
| E. R. Squibb & Sons, Inc. | 1 | 1981-01-08 |
| Suburban Ostomy Supply Co., Inc. | 1 | 1979-07-30 |
| Atlantic Surgical | 1 | 1977-02-28 |
Most recent EZR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844341 | Howmedica Corp. | UNITED SKIN BARRIER PASTE | 1985-01-18 | 71 |
| K803100 | E. R. Squibb & Sons, Inc. | STOMAHESIVE PASTE PROTECTIVE SKIN BARR | 1981-01-08 | 30 |
| K791146 | Suburban Ostomy Supply Co., Inc. | COLO-TAPE | 1979-07-30 | 42 |
| K761340 | Howmedica Corp. | OSTOMY KARAYA GUM POWDER | 1977-03-07 | 69 |
| K770230 | Atlantic Surgical | KARAYA GUM POWDER | 1977-02-28 | 21 |
Recalls for EZR devices
openFDA lists no recalls for product code EZR.
Frequently asked questions
What is FDA product code EZR?
EZR is the FDA product code for cement, stomal appliance, ostomy. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel.
What device class is EZR?
Class I, regulation 21 CFR 876.5900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EZR?
Across 6 cleared submissions the average was 47 days from receipt to decision (median 46).
Which companies have the most EZR clearances?
Howmedica Corp. (3); E. R. Squibb & Sons, Inc. (1); Suburban Ostomy Supply Co., Inc. (1); Atlantic Surgical (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EZR
- Run a recall and safety report across every EZR manufacturer
- Watch product code EZR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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