FDA product code EZP: Rod, Colostomy
EZP is the FDA product code for rod, colostomy. It is a Class II device, regulated under 21 CFR 876.4270 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under EZP, from 2 different applicants. The average 510(k) review took 244 days (median 244).
Classification
| Field | Value |
|---|---|
| Device name | Rod, Colostomy |
| Device class | Class II |
| Regulation | 21 CFR 876.4270 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EZP clearance
Top EZP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coloplast Corp. | 1 | 2006-10-13 |
| Tools For Surgery, LLC | 1 | 2004-03-24 |
Most recent EZP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052229 | Coloplast Corp. | COLOPLAST OSTOMY ROD, MODEL 12814 | 2006-10-13 | 423 |
| K040110 | Tools For Surgery, LLC | EASY LOOP, MODEL EZL-01 | 2004-03-24 | 64 |
Recalls for EZP devices
openFDA lists no recalls for product code EZP.
Frequently asked questions
What is FDA product code EZP?
EZP is the FDA product code for rod, colostomy. It is a Class II device, regulated under 21 CFR 876.4270 and reviewed by the Gastroenterology and Urology panel.
What device class is EZP?
Class II, regulation 21 CFR 876.4270. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EZP?
Across 2 cleared submissions the average was 244 days from receipt to decision (median 244).
Which companies have the most EZP clearances?
Coloplast Corp. (1); Tools For Surgery, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EZP
- Run a recall and safety report across every EZP manufacturer
- Watch product code EZP 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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