FDA product code EZN: Dilator, Catheter, Ureteral
EZN is the FDA product code for dilator, catheter, ureteral. It is a Class II device, regulated under 21 CFR 876.5470 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 56 510(k) submissions under EZN, 2 in the last five years, from 25 different applicants. The average 510(k) review took 106 days (median 80); 57 days on average over the last three years. FDA has posted 14 recalls for EZN devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Catheter, Ureteral |
| Device class | Class II |
| Regulation | 21 CFR 876.5470 |
| 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 EZN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 176 |
| 2018 | 4 | 162 |
| 2019 | 1 | 270 |
| 2020 | 1 | 55 |
| 2023 | 1 | 414 |
| 2025 | 1 | 57 |
Compare with all 510(k) review times · Search every EZN clearance
Top EZN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corp | 8 | 1998-04-22 |
| Cook Urological, Inc. | 5 | 2004-04-06 |
| American Edwards Laboratories | 5 | 1985-08-21 |
| Cook Incorporated | 4 | 2018-07-17 |
| Van-Tec, Inc. | 4 | 1987-03-10 |
20 more applicants have EZN clearances. See the full list in Caduvo.
Most recent EZN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250910 | Urotronic, Inc. | Optilume® High Pressure Urological Balloon Dilation Catheter | 2025-05-22 | 57 |
| K220781 | Allwin Medical Devices, Inc. | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter | 2023-05-05 | 414 |
| K201007 | Coloplast Corp. | In-Ka Ureteral Balloon Dilatation Catheter | 2020-06-11 | 55 |
| K190612 | Dornier Medtech America, Inc. | EQUINOX Balloon Dilatation Catheter | 2019-12-06 | 270 |
| K173654 | Cook Incorporated | Ureteral Dilator Sets, Ureteral Dilators | 2018-07-17 | 231 |
Recalls for EZN devices
14 product recalls in 5 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-08-05.
| Year | Recalls |
|---|---|
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code EZN?
EZN is the FDA product code for dilator, catheter, ureteral. It is a Class II device, regulated under 21 CFR 876.5470 and reviewed by the Gastroenterology and Urology panel.
What device class is EZN?
Class II, regulation 21 CFR 876.5470. Typical premarket route: 510(k).
How long does a 510(k) take for product code EZN?
Across 56 cleared submissions the average was 106 days from receipt to decision (median 80).
Which companies have the most EZN clearances?
Boston Scientific Corp (8); Cook Urological, Inc. (5); American Edwards Laboratories (5); Cook Incorporated (4); Van-Tec, Inc. (4).
Have EZN devices been recalled?
Yes: 14 product recalls across 5 recall events; the most recent began 2025-08-05.
Next steps
- Run an FDA pathway report with predicate devices for product code EZN
- Run a recall and safety report across every EZN manufacturer
- Watch product code EZN 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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