FDA product code EZC: Catheter, Coude
EZC is the FDA product code for catheter, coude. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 7 510(k) submissions under EZC, 1 in the last five years, from 3 different applicants. The average 510(k) review took 137 days (median 170). FDA has posted 11 recalls for EZC devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Coude |
| Device class | Class II |
| Regulation | 21 CFR 876.5130 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EZC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 69 |
| 2022 | 1 | 31 |
Compare with all 510(k) review times · Search every EZC clearance
Top EZC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 4 | 1992-01-27 |
| Teleflex Medical | 2 | 2022-08-29 |
| Louisville Laboratories, Inc. | 1 | 1995-03-31 |
Most recent EZC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222279 | Teleflex Medical | Rusch Intermittent Urethral Catheters | 2022-08-29 | 31 |
| K173596 | Teleflex Medical | Rusch Intermittent Urethral Catheters | 2018-01-29 | 69 |
| K946282 | Louisville Laboratories, Inc. | UNIVERSAL URETHRAL CATHETER | 1995-03-31 | 94 |
| K913341 | C.R. Bard, Inc. | BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER | 1992-01-27 | 185 |
| K910846 | C.R. Bard, Inc. | BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF | 1991-08-16 | 170 |
Recalls for EZC devices
11 product recalls in 5 recall events; 2 initiated in the last five years and 9 still open. Most recent: 2026-06-25.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2021 | 7 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code EZC?
EZC is the FDA product code for catheter, coude. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is EZC?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code EZC?
Across 7 cleared submissions the average was 137 days from receipt to decision (median 170).
Which companies have the most EZC clearances?
C.R. Bard, Inc. (4); Teleflex Medical (2); Louisville Laboratories, Inc. (1).
Have EZC devices been recalled?
Yes: 11 product recalls across 5 recall events; the most recent began 2026-06-25.
Next steps
- Run an FDA pathway report with predicate devices for product code EZC
- Run a recall and safety report across every EZC manufacturer
- Watch product code EZC 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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