FDA product code EZK: Catheter, Retention Type
EZK is the FDA product code for catheter, retention type. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under EZK, from 3 different applicants. The average 510(k) review took 228 days (median 72).
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Retention Type |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every EZK clearance
Top EZK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E-Z-Em, Inc. | 1 | 1992-11-16 |
| Respiratory Support Products, Inc. | 1 | 1990-10-31 |
| Howmedica Corp. | 1 | 1977-03-15 |
Most recent EZK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911349 | E-Z-Em, Inc. | E-Z-EM ENTEROCLYSIS CATHETER SET | 1992-11-16 | 600 |
| K903816 | Respiratory Support Products, Inc. | URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR | 1990-10-31 | 72 |
| K770408 | Howmedica Corp. | KARAYA GUM POWDER, OSTOMY | 1977-03-15 | 11 |
Recalls for EZK devices
openFDA lists no recalls for product code EZK.
Frequently asked questions
What is FDA product code EZK?
EZK is the FDA product code for catheter, retention type. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is EZK?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code EZK?
Across 3 cleared submissions the average was 228 days from receipt to decision (median 72).
Which companies have the most EZK clearances?
E-Z-Em, Inc. (1); Respiratory Support Products, Inc. (1); Howmedica Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EZK
- Run a recall and safety report across every EZK manufacturer
- Watch product code EZK 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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