FDA product code EZD: Catheter, Straight
EZD is the FDA product code for catheter, straight. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 86 510(k) submissions under EZD, 37 in the last five years, from 49 different applicants. The average 510(k) review took 157 days (median 139); 148 days on average over the last three years. FDA has posted 13 recalls for EZD devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Straight |
| 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 EZD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 158 |
| 2018 | 3 | 130 |
| 2020 | 1 | 26 |
| 2022 | 10 | 297 |
| 2023 | 6 | 216 |
| 2024 | 5 | 155 |
| 2025 | 6 | 148 |
| 2026 | 10 | 140 |
Compare with all 510(k) review times · Search every EZD clearance
Top EZD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coloplast Corp. | 6 | 2025-06-27 |
| Coloplast | 6 | 2024-07-26 |
| Hollister Incorporated | 5 | 2026-05-18 |
| C.R. Bard, Inc. | 5 | 2017-09-20 |
| Convatec | 3 | 2026-08-05 |
44 more applicants have EZD clearances. See the full list in Caduvo.
Most recent EZD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260737 | Convatec | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). | 2026-08-05 | 152 |
| K261658 | Wellspect AB | LoFric Origo Pro Coudé | 2026-07-17 | 59 |
| K262045 | Coloplast A.S. | Luja Soft | 2026-07-07 | 20 |
| K260394 | Hangzhou Jimushi Meditech Co., Ltd. | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) | 2026-06-24 | 138 |
| K253295 | Hollister Incorporated | Coude Sleeved IC; Coude Plus Sleeved IC | 2026-05-18 | 231 |
Recalls for EZD devices
13 product recalls in 6 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2023-04-20.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2020 | 3 |
| 2023 | 4 |
Frequently asked questions
What is FDA product code EZD?
EZD is the FDA product code for catheter, straight. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is EZD?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code EZD?
Across 86 cleared submissions the average was 157 days from receipt to decision (median 139).
Which companies have the most EZD clearances?
Coloplast Corp. (6); Coloplast (6); Hollister Incorporated (5); C.R. Bard, Inc. (5); Convatec (3).
Have EZD devices been recalled?
Yes: 13 product recalls across 6 recall events; the most recent began 2023-04-20.
Next steps
- Run an FDA pathway report with predicate devices for product code EZD
- Run a recall and safety report across every EZD manufacturer
- Watch product code EZD 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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